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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 K961072
Device Name PEC IMPLANT
Applicant
RAND SCIENTIFIC CORP.
4135 NORTHGATE BLVD.
SUITE 9
SACRAMENTO,  CA  95834
Applicant Contact DUANE TRACY
Correspondent
RAND SCIENTIFIC CORP.
4135 NORTHGATE BLVD.
SUITE 9
SACRAMENTO,  CA  95834
Correspondent Contact DUANE TRACY
Regulation Number874.3620
Classification Product Code
MIC  
Date Received03/18/1996
Decision Date 04/19/1996
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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