Cleared Traditional

SURGICAL DRAPES, MODIFICATION

K931146 · Amsco Sterile Recoveries, Inc. · General Hospital
Jun 1994
Decision
465d
Days
Class 2
Risk

About This 510(k) Submission

K931146 is an FDA 510(k) clearance for the SURGICAL DRAPES, MODIFICATION, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on June 13, 1994, 465 days after receiving the submission on March 5, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K931146 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1993
Decision Date June 13, 1994
Days to Decision 465 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KKX — Drape, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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