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FDA 510(k)

EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)

K-Number: K964334 · 1996-12-09

ApplicantShippert Medical Technologies Corp.
Decision Date1996-12-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) is the device name listed in this FDA 510(k) record. The listed applicant is Shippert Medical Technologies Corp.. It received FDA 510(k) clearance on 1996-12-09 under 510(k) number K964334. 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 EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)?

EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) is a medical device that received FDA 510(k) clearance on 1996-12-09. The listed applicant is Shippert Medical Technologies Corp.. The 510(k) number is K964334.

When did EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) receive FDA 510(k) clearance?

EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) received FDA 510(k) clearance on 1996-12-09, under 510(k) number K964334.

Who is the listed applicant for EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)?

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

What is the FDA product code for EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)?

The FDA product code for EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) is GCJ.

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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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