Cleared Traditional

SERAGARD INJECTION PATCH

K001240 · Platinum Services, Inc. · General & Plastic Surgery

Jun 2000

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K001240 is an FDA 510(k) clearance for the SERAGARD INJECTION PATCH, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Platinum Services, Inc. (Dequincy, US). The FDA issued a Cleared decision on June 21, 2000, 64 days after receiving the submission on April 18, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number	K001240 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2000
Decision Date	June 21, 2000
Days to Decision	64 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF