Derma-Aid

FDA 510(k) K820198 · Winfield Laboratories, Inc.

Substantially Equivalent

510(k) numberK820198

Submission

Device name
Derma-Aid
Applicant
Winfield Laboratories, Inc.
Mchenry, IL, US
Received
January 25, 1982
Decision date
March 5, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code NAB

510(k)DeviceApplicantDecision
K946015Ivalon External SpongeNAB · Traditional Ivalon02/27/1995SE
K940755Isolyer (4X4, 8PLY)NAB · Traditional Isolyer Co.05/02/1994SE
K931610Omnisorb II, Nonwoven Sponge, Sterile and NonNAB · Traditional Omni Mfg., Inc.06/24/1993SE
K925590Multi-Trauma DressingNAB · Traditional Gam Industries, Inc.04/08/1993SE
K926072K-Band and K-CrepeNAB · Traditional Parema , Ltd.03/19/1993SE
K915591Sterile Gauze PadsNAB · Traditional Eagle Medical, Inc.01/27/1993SE
K924650Gauze SpongesNAB · Traditional Dav-Mar Medical Products, Inc.01/11/1993SE
K923602Absorbent Pad -- ModificationNAB · Traditional Winfield Laboratories, Inc.12/07/1992SE
K923115ClinisorbNAB · Traditional Hermitage Hospital Products, Inc.11/23/1992SE
K923378Usp Type Vii Gauze SpongesNAB · Traditional E.W.A., Ltd.10/06/1992SE

More from E.W.A., Ltd.

510(k)DeviceDecision
K973538N-TerfaceMGP · Traditional 12/16/1997SN
K923602Absorbent Pad -- ModificationNAB · Traditional 12/07/1992SE
K872069Kontour Ultra Soft Sponge #SS144.50NAD · Traditional 07/14/1987SN

Questions and answers

When was Derma-Aid cleared by the FDA?

Derma-Aid (K820198) received a 510(k) decision of Substantially Equivalent on March 5, 1982, 39 days after the submission was received.

What is the product code of K820198?

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