Absorbent Pad -- Modification

FDA 510(k) K923602 · Winfield Laboratories, Inc.

Substantially Equivalent

510(k) numberK923602

Submission

Device name
Absorbent Pad -- Modification
Applicant
Winfield Laboratories, Inc.
Richardson, TX, US
Received
July 15, 1992
Decision date
December 7, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NAB – Gauze / Sponge,Nonresorbable For External Use
Device class
Class I (low risk)
Regulation
21 CFR 878.4014
Specialty
General, Plastic Surgery

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K915591Sterile Gauze PadsNAB · Traditional Eagle Medical, Inc.01/27/1993SE
K924650Gauze SpongesNAB · Traditional Dav-Mar Medical Products, Inc.01/11/1993SE
K923115ClinisorbNAB · Traditional Hermitage Hospital Products, Inc.11/23/1992SE
K923378Usp Type Vii Gauze SpongesNAB · Traditional E.W.A., Ltd.10/06/1992SE
K923116Combine II Wetproof PadNAB · Traditional Hermitage Hospital Products, Inc.10/06/1992SE

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K973538N-TerfaceMGP · Traditional 12/16/1997SN
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K820198Derma-AidNAB · Traditional 03/05/1982SE

Questions and answers

When was Absorbent Pad -- Modification cleared by the FDA?

Absorbent Pad -- Modification (K923602) received a 510(k) decision of Substantially Equivalent on December 7, 1992, 145 days after the submission was received.

What is the product code of K923602?

The FDA product code is NAB – Gauze / Sponge,Nonresorbable For External Use, a Class I (low risk) device regulated under 21 CFR 878.4014.