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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 And Burn, Occlusive
510(k) Number K983394
Device Name MODIFICATION TO TIELLE HYDROPOLMER DRESSING
Applicant
Johnson & Johnson Medical, Div. of Ethicon, Inc.
2500 Arbrook Bl
Arlington,  TX  76004
Applicant Contact TERRY J DAGNON
Correspondent
Johnson & Johnson Medical, Div. of Ethicon, Inc.
2500 Arbrook Bl
Arlington,  TX  76004
Correspondent Contact TERRY J DAGNON
Classification Product Code
MGP  
Date Received09/25/1998
Decision Date 11/03/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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