FDA 510(k)

LAPAROMED HOOK/SPATULA DEVICE

K-Number: K910074 · 1991-07-02

Decision Date1991-07-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LAPAROMED HOOK/SPATULA DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Laparomed Corp.. It received FDA 510(k) clearance on 1991-07-02 under 510(k) number K910074. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROMED HOOK/SPATULA DEVICE?

LAPAROMED HOOK/SPATULA DEVICE is a medical device that received FDA 510(k) clearance on 1991-07-02. The listed applicant is Laparomed Corp.. The 510(k) number is K910074.

When did LAPAROMED HOOK/SPATULA DEVICE receive FDA 510(k) clearance?

LAPAROMED HOOK/SPATULA DEVICE received FDA 510(k) clearance on 1991-07-02, under 510(k) number K910074.

Who is the listed applicant for LAPAROMED HOOK/SPATULA DEVICE?

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

What is the FDA product code for LAPAROMED HOOK/SPATULA DEVICE?

The FDA product code for LAPAROMED HOOK/SPATULA DEVICE is GEI.

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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.