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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 K072560
Device Name ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
Applicant
Teikoku Pharma USA, Inc.
1718 Ringwood Ave.
San Jose,  CA  95131 -1711
Applicant Contact MARGIE NEMCIK-CRUZ
Correspondent
Teikoku Pharma USA, Inc.
1718 Ringwood Ave.
San Jose,  CA  95131 -1711
Correspondent Contact MARGIE NEMCIK-CRUZ
Regulation Number878.4020
Classification Product Code
NAD  
Date Received09/11/2007
Decision Date 06/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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