Cleared Traditional

K931669 - CARAPACE DEBRIDEMENT KITS
(FDA 510(k) Clearance)

K931669 · Carapace, Inc. · General Hospital

Feb 1994

Decision

307d

Days

Class 2

Risk

K931669 is an FDA 510(k) clearance for the CARAPACE DEBRIDEMENT KITS, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on February 7, 1994, 307 days after receiving the submission on April 6, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K931669 FDA.gov
FDA Decision	Cleared SESK
Date Received	April 06, 1993
Decision Date	February 07, 1994
Days to Decision	307 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement