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FDA 510(k)

PHACO PACKS, 1A PACKS & PACK COMPONENTS

K-Number: K854116 · 1985-12-27

ApplicantMedical Corp. of America
Decision Date1985-12-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHACO PACKS, 1A PACKS & PACK COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Corp. of America. It received FDA 510(k) clearance on 1985-12-27 under 510(k) number K854116. 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 PHACO PACKS, 1A PACKS & PACK COMPONENTS?

PHACO PACKS, 1A PACKS & PACK COMPONENTS is a medical device that received FDA 510(k) clearance on 1985-12-27. The listed applicant is Medical Corp. of America. The 510(k) number is K854116.

When did PHACO PACKS, 1A PACKS & PACK COMPONENTS receive FDA 510(k) clearance?

PHACO PACKS, 1A PACKS & PACK COMPONENTS received FDA 510(k) clearance on 1985-12-27, under 510(k) number K854116.

Who is the listed applicant for PHACO PACKS, 1A PACKS & PACK COMPONENTS?

The FDA 510(k) record lists Medical Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHACO PACKS, 1A PACKS & PACK COMPONENTS?

The FDA product code for PHACO PACKS, 1A PACKS & PACK COMPONENTS 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.

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Other records listing Medical Corp. of America 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.

K860957DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.K860956KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.K853883TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR

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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