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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K823036
Device Name AUTOCLAVE TESTING ADHESIVE TAPE
Applicant
INDUSTRIAS TUK, S.A. DE C.V.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INDUSTRIAS TUK, S.A. DE C.V.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received10/14/1982
Decision Date 11/08/1982
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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