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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 K811670
Device Name STERI-LOK DUAL PURPOSE PACKAGING/8400
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number880.6850
Classification Product Code
FRG  
Date Received06/15/1981
Decision Date 07/10/1981
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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