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FDA 510(k)

SKIN SAVER SYSTEMS

K-Number: K952738 · 1995-09-29

ApplicantSkin Saver Systems, Inc.
Decision Date1995-09-29
Product CodeFQM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKIN SAVER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Skin Saver Systems, Inc.. It received FDA 510(k) clearance on 1995-09-29 under 510(k) number K952738. The device is classified under product code FQM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN SAVER SYSTEMS?

SKIN SAVER SYSTEMS is a medical device that received FDA 510(k) clearance on 1995-09-29. The listed applicant is Skin Saver Systems, Inc.. The 510(k) number is K952738.

When did SKIN SAVER SYSTEMS receive FDA 510(k) clearance?

SKIN SAVER SYSTEMS received FDA 510(k) clearance on 1995-09-29, under 510(k) number K952738.

Who is the listed applicant for SKIN SAVER SYSTEMS?

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

What is the FDA product code for SKIN SAVER SYSTEMS?

The FDA product code for SKIN SAVER SYSTEMS is FQM.

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Official Source

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