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FDA 510(k)

ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK

K-Number: K850532 · 1985-04-15

ApplicantAtlantic Optical Systems, Inc.
Decision Date1985-04-15
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Optical Systems, Inc.. It received FDA 510(k) clearance on 1985-04-15 under 510(k) number K850532. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK?

ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK is a medical device that received FDA 510(k) clearance on 1985-04-15. The listed applicant is Atlantic Optical Systems, Inc.. The 510(k) number is K850532.

When did ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK receive FDA 510(k) clearance?

ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK received FDA 510(k) clearance on 1985-04-15, under 510(k) number K850532.

Who is the listed applicant for ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK?

The FDA 510(k) record lists Atlantic Optical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK?

The FDA product code for ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK is HQC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Atlantic Optical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K850533ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEMK834155UNIVERSAL PACKK831701UNIVERSAL PACK

Related Devices (Code: HQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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