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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name facial implant
510(k) Number K071823
Device Name PERMA FACIAL IMPLANTS
Applicant
SURGISIL
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA J NOLTE
Correspondent
SURGISIL
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA J NOLTE
Regulation Number878.3500
Classification Product Code
ODU  
Date Received07/03/2007
Decision Date 09/19/2007
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
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