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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Muscle, Pectoralis
510(k) Number K913768
Device Name PEC IMPLANT
Applicant
Applied Biomaterial Technologies
3500 NW Anderson Hill Rd.
Suite #101
Silverdale,  WA  98383
Applicant Contact GERALD L HANSON
Correspondent
Applied Biomaterial Technologies
3500 NW Anderson Hill Rd.
Suite #101
Silverdale,  WA  98383
Correspondent Contact GERALD L HANSON
Regulation Number874.3620
Classification Product Code
MIC  
Date Received08/22/1991
Decision Date 02/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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