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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 K801824
Device Name BAND-AID BRAND FLEXIBLE FABRIC BANDAGE
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Regulation Number878.4100
Classification Product Code
KGY  
Date Received07/31/1980
Decision Date 08/20/1980
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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