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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, Occlusive
510(k) Number K884791
Device Name PERME-AID TRANSPARENT DRESSING, #11XX
Applicant
Nitto Denko Technical Corp.
2910 Corvin Dr.
Santa Clara,  CA  95051
Applicant Contact MARK TSUJI
Correspondent
Nitto Denko Technical Corp.
2910 Corvin Dr.
Santa Clara,  CA  95051
Correspondent Contact MARK TSUJI
Regulation Number878.4020
Classification Product Code
NAD  
Date Received11/15/1988
Decision Date 05/04/1989
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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