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FDA 510(k)

PENEVAC ABC HANDPIECE

K-Number: K955020 · 1996-04-09

ApplicantI.C Medical, Inc.
Decision Date1996-04-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PENEVAC ABC HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is I.C Medical, Inc.. It received FDA 510(k) clearance on 1996-04-09 under 510(k) number K955020. 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 PENEVAC ABC HANDPIECE?

PENEVAC ABC HANDPIECE is a medical device that received FDA 510(k) clearance on 1996-04-09. The listed applicant is I.C Medical, Inc.. The 510(k) number is K955020.

When did PENEVAC ABC HANDPIECE receive FDA 510(k) clearance?

PENEVAC ABC HANDPIECE received FDA 510(k) clearance on 1996-04-09, under 510(k) number K955020.

Who is the listed applicant for PENEVAC ABC HANDPIECE?

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

What is the FDA product code for PENEVAC ABC HANDPIECE?

The FDA product code for PENEVAC ABC HANDPIECE is GEI.

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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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