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FDA 510(k)

DM001 DISPOSABLE PACK

K-Number: K953539 · 1995-12-26

ApplicantAmerican Optisurgical, Inc.
Decision Date1995-12-26
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DM001 DISPOSABLE PACK is the device name listed in this FDA 510(k) record. The listed applicant is American Optisurgical, Inc.. It received FDA 510(k) clearance on 1995-12-26 under 510(k) number K953539. 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 DM001 DISPOSABLE PACK?

DM001 DISPOSABLE PACK is a medical device that received FDA 510(k) clearance on 1995-12-26. The listed applicant is American Optisurgical, Inc.. The 510(k) number is K953539.

When did DM001 DISPOSABLE PACK receive FDA 510(k) clearance?

DM001 DISPOSABLE PACK received FDA 510(k) clearance on 1995-12-26, under 510(k) number K953539.

Who is the listed applicant for DM001 DISPOSABLE PACK?

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

What is the FDA product code for DM001 DISPOSABLE PACK?

The FDA product code for DM001 DISPOSABLE PACK is HQC.

Related Clinical Trials

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Other records listing American Optisurgical, 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.

K101561TX1 TISSUE REMOVAL SYSTEMK080803VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551K020527HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030K953538RM001 REUSABLEK952331AOI LC-40 PHACOEMULSIFIER

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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