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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Nose, Internal
510(k) Number K952708
Device Name PECTORALIS IMPLANT
Applicant
SPIRIT RIDGE TECHNOLOGIES
19325 58TH PLANCE N.E.
SEATTLE,  WA  98155
Applicant Contact KATHTY RICHARDSON
Correspondent
SPIRIT RIDGE TECHNOLOGIES
19325 58TH PLANCE N.E.
SEATTLE,  WA  98155
Correspondent Contact KATHTY RICHARDSON
Regulation Number878.3680
Classification Product Code
FZE  
Subsequent Product Codes
FWP   LZK   MIB   MIC  
Date Received06/14/1995
Decision Date 08/28/1995
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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