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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone Block
510(k) Number K961081
Device Name SPIRIT RIDGE SILICONE CARVING BLOCK
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
MIB  
Date Received03/18/1996
Decision Date 05/22/1996
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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