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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Dressing, Wound, Drug
510(k) Number K852545
Device Name BAND-AID BRAND ADHESIVE BANDAGES
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact OMEGA NORTON-CRABLE
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact OMEGA NORTON-CRABLE
Classification Product Code
FRO  
Date Received06/14/1985
Decision Date 09/05/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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