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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 K962590
Device Name SIGNALDRESS
Applicant
Convatec, A Division of E.R. Squibb & Sons
100 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact ADRIENNE MCNALLY
Correspondent
Convatec, A Division of E.R. Squibb & Sons
100 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact ADRIENNE MCNALLY
Classification Product Code
FRO  
Date Received07/02/1996
Decision Date 09/20/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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