Cleared Traditional

K012957 - TOWEL DRAPE, MODELS 4409, 4410
(FDA 510(k) Clearance)

K012957 · Dynarex Corp. · General Hospital

Mar 2002

Decision

183d

Days

Class 2

Risk

K012957 is an FDA 510(k) clearance for the TOWEL DRAPE, MODELS 4409, 4410, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Dynarex Corp. (Mainville, US). The FDA issued a Cleared decision on March 6, 2002, 183 days after receiving the submission on September 4, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K012957 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 2001
Decision Date	March 06, 2002
Days to Decision	183 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF