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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K931143
Device Name AMSCO STERILE RECOVERIES ABSORBENT TOWELS
Applicant
Amsco Sterile Recoveries, Inc.
28100 U.S. Hwy., 19n., Suite 201
Clearwater,  FL  34621
Applicant Contact DENISE A SCHOTTLER
Correspondent
Amsco Sterile Recoveries, Inc.
28100 U.S. Hwy., 19n., Suite 201
Clearwater,  FL  34621
Correspondent Contact DENISE A SCHOTTLER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/05/1993
Decision Date 09/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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