Cleared Traditional

RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE

K931874 · Amsco Sterile Recoveries, Inc. · General Hospital
Jun 1994
Decision
422d
Days
Class 2
Risk

About This 510(k) Submission

K931874 is an FDA 510(k) clearance for the RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on June 10, 1994, 422 days after receiving the submission on April 14, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K931874 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1993
Decision Date June 10, 1994
Days to Decision 422 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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