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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 K984593
Device Name MODIFICATION OF CUTINOVA THIN DRESSING
Applicant
Beiersdorf-Jobt, Inc.
5825 Carnegie Blvd.
Charlotte,  NC  28209
Applicant Contact ANGELO R PEREIRA
Correspondent
Beiersdorf-Jobt, Inc.
5825 Carnegie Blvd.
Charlotte,  NC  28209
Correspondent Contact ANGELO R PEREIRA
Classification Product Code
FRO  
Date Received12/28/1998
Decision Date 03/01/1999
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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