Cleared Traditional

K964846 - IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
(FDA 510(k) Clearance)

K964846 · Implantech Associates, Inc. · General & Plastic Surgery device

Feb 1997

Decision

71d

Days

Class 1

Risk

K964846 is an FDA 510(k) clearance for the IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING. This device is classified as a Elastomer, Silicone, For Scar Management (Class I - General Controls, product code MDA).

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on February 12, 1997, 71 days after receiving the submission on December 3, 1996.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4025.

Submission Details

510(k) Number	K964846 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 03, 1996
Decision Date	February 12, 1997
Days to Decision	71 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement