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FDA 510(k)

LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE

K-Number: K972984 · 1997-10-29

ApplicantLerner Medical, Inc.
Decision Date1997-10-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Lerner Medical, Inc.. It received FDA 510(k) clearance on 1997-10-29 under 510(k) number K972984. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE?

LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is Lerner Medical, Inc.. The 510(k) number is K972984.

When did LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE receive FDA 510(k) clearance?

LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE received FDA 510(k) clearance on 1997-10-29, under 510(k) number K972984.

Who is the listed applicant for LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE?

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

What is the FDA product code for LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE?

The FDA product code for LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE is GCJ.

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Related Devices (Code: GCJ)

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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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