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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 K801569
Device Name VAL-U-WRAP CSR WRAP
Applicant
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6850
Classification Product Code
FRG  
Date Received07/08/1980
Decision Date 07/28/1980
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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