Cleared Traditional

K991694 - DYNAREX DRAIN SPONGE
(FDA 510(k) Clearance)

K991694 · Dynarex Corp. · General & Plastic Surgery

Jul 1999

Decision

58d

Days

Class 1

Risk

K991694 is an FDA 510(k) clearance for the DYNAREX DRAIN SPONGE. This device is classified as a Bandage, Liquid (Class I — General Controls, product code KMF).

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on July 15, 1999, 58 days after receiving the submission on May 18, 1999.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number	K991694 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1999
Decision Date	July 15, 1999
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement