Multiple Sterile Gauze Bandage Rolls, Vari Sizes

FDA 510(k) K915821 · Kerma Medical Products, Inc.

Substantially Equivalent

510(k) numberK915821

Submission

Device name
Multiple Sterile Gauze Bandage Rolls, Vari Sizes
Applicant
Kerma Medical Products, Inc.
Chesapeake, VA, US
Received
December 30, 1991
Decision date
May 29, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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
K931042Moore Secure CapLYU · Traditional 04/13/1994SE
K915822Multiple Dressing, Sterile Nonaddherent PadsNAB · Traditional 03/26/1992SE
K914937Sterile Bandage, Gauze, Fine Mesh, 3X8 InchesNAB · Traditional 12/04/1991SE
K914071Multiple Burn DressingNAB · Traditional 12/04/1991SE

Questions and answers

When was Multiple Sterile Gauze Bandage Rolls, Vari Sizes cleared by the FDA?

Multiple Sterile Gauze Bandage Rolls, Vari Sizes (K915821) received a 510(k) decision of Substantially Equivalent on May 29, 1992, 151 days after the submission was received.

What is the product code of K915821?

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