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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K931874
Device Name RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE
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 Number880.6850
Classification Product Code
FRG  
Date Received04/14/1993
Decision Date 06/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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