Cleared Traditional

AMSCO STERILE RECOVERIES SURGICAL PACKS

K932522 · Amsco Sterile Recoveries, Inc. · Ear, Nose, Throat

Sep 1994

Decision

472d

Days

Class 1

Risk

About This 510(k) Submission

K932522 is an FDA 510(k) clearance for the AMSCO STERILE RECOVERIES SURGICAL PACKS, a Applicator, Ent Drug (Class I — General Controls, product code LRD), submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on September 9, 1994, 472 days after receiving the submission on May 25, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5220.

Submission Details

510(k) Number	K932522 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 1993
Decision Date	September 09, 1994
Days to Decision	472 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement