Hydrasorb Joyce Sponge

FDA 510(k) K925841 · Avitar, Inc.

Substantially Equivalent

510(k) numberK925841

Submission

Device name
Hydrasorb Joyce Sponge
Applicant
Avitar, Inc.
Canton, MA, US
Received
November 18, 1992
Decision date
May 12, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NAC – Dressing, Wound, Hydrophilic
Device class
Class I (low risk)
Regulation
21 CFR 878.4018
Specialty
General, Plastic Surgery

Other 510(k)s with product code NAC

510(k)DeviceApplicantDecision
K082208Doctors Choice Slow Healing Bandage with Spray on RemoverNAC · Traditional Scivolutions, Inc.12/01/2008SE
K914779Alginate FiberNAC · Traditional Adri/Technam12/04/1991SE
K914575Sorbsan Topical Wound Dressing (Modified)NAC · Traditional Dow B. Hickam, Inc.12/04/1991SE

More from Dow B. Hickam, Inc.

510(k)DeviceDecision
K973260Hydrasorb Sterile DressingMGP · Traditional 10/21/1997SE
K897102Hydrasorb(Tm)JOH · Traditional 04/23/1990SE
K897156Hydrasorb(Tm)NAD · Traditional 02/21/1990SE

Questions and answers

When was Hydrasorb Joyce Sponge cleared by the FDA?

Hydrasorb Joyce Sponge (K925841) received a 510(k) decision of Substantially Equivalent on May 12, 1993, 175 days after the submission was received.

What is the product code of K925841?

The FDA product code is NAC – Dressing, Wound, Hydrophilic, a Class I (low risk) device regulated under 21 CFR 878.4018.