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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Intestine
510(k) Number K832318
Device Name ISOLATION BAG 3M
Applicant
3M Company
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent
3M Company
2724 S. Peck Rd.
Monrovia,  CA  91016
Regulation Number878.4100
Classification Product Code
KGY  
Date Received07/15/1983
Decision Date 10/31/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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