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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Skin Closure
510(k) Number K962144
Device Name PHOENIX ETE TISSUE EXTENSION SYSTEM
Applicant
Phoenix Biomedical Corp.
P.O. Box 80390
Norristown,  PA  19403
Applicant Contact HORACE J WILMER
Correspondent
Phoenix Biomedical Corp.
P.O. Box 80390
Norristown,  PA  19403
Correspondent Contact HORACE J WILMER
Regulation Number878.4320
Classification Product Code
MKY  
Date Received06/03/1996
Decision Date 01/14/1997
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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