Cleared Traditional

SPYROFLEX WOUND CLOSURES

K921775 · Polymint Industrial Co. , Ltd. · General & Plastic Surgery

May 1992

Decision

39d

Days

Class 1

Risk

About This 510(k) Submission

K921775 is an FDA 510(k) clearance for the SPYROFLEX WOUND CLOSURES, a Strip, Adhesive, Closure, Skin (Class I — General Controls, product code FPX), submitted by Polymint Industrial Co. , Ltd. (Wheat Ridge, US). The FDA issued a Cleared decision on May 19, 1992, 39 days after receiving the submission on April 10, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number	K921775 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 1992
Decision Date	May 19, 1992
Days to Decision	39 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement