Cleared Traditional

SPYROGEL WOUND DRESSING

K932457 · Polymint Industrial Co. , Ltd. · General & Plastic Surgery

Feb 1994

Decision

264d

Days

Class 1

Risk

About This 510(k) Submission

K932457 is an FDA 510(k) clearance for the SPYROGEL WOUND DRESSING, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Polymint Industrial Co. , Ltd. (Golden,, US). The FDA issued a Cleared decision on February 9, 1994, 264 days after receiving the submission on May 21, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number	K932457 FDA.gov
FDA Decision	Cleared SN
Date Received	May 21, 1993
Decision Date	February 09, 1994
Days to Decision	264 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—