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FDA 510(k)

KCP PAK CONVENIENCE PACK

K-Number: K850148 · 1985-04-15

ApplicantCooperVision, Inc.
Decision Date1985-04-15
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KCP PAK CONVENIENCE PACK is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1985-04-15 under 510(k) number K850148. 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 KCP PAK CONVENIENCE PACK?

KCP PAK CONVENIENCE PACK is a medical device that received FDA 510(k) clearance on 1985-04-15. The listed applicant is CooperVision, Inc.. The 510(k) number is K850148.

When did KCP PAK CONVENIENCE PACK receive FDA 510(k) clearance?

KCP PAK CONVENIENCE PACK received FDA 510(k) clearance on 1985-04-15, under 510(k) number K850148.

Who is the listed applicant for KCP PAK CONVENIENCE PACK?

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

What is the FDA product code for KCP PAK CONVENIENCE PACK?

The FDA product code for KCP PAK CONVENIENCE PACK is HQC.

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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

View on FDA Database →

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

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