Cleared Traditional

AMSCO STERILE RECOVERIES ABSORBENT TOWELS

K931143 · Amsco Sterile Recoveries, Inc. · General Hospital
Sep 1994
Decision
552d
Days
Class 2
Risk

About This 510(k) Submission

K931143 is an FDA 510(k) clearance for the AMSCO STERILE RECOVERIES ABSORBENT TOWELS, 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 September 8, 1994, 552 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 K931143 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1993
Decision Date September 08, 1994
Days to Decision 552 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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