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FDA 510(k) Application Details - K961057
Device Classification Name
Elastomer, Silicone Block
More FDA Info for this Device
510(K) Number
K961057
Device Name
Elastomer, Silicone Block
Applicant
RAND SCIENTIFIC CORP.
4135 NORTHGATE BLVD.
SUITE 9
SACRAMENTO, CA 95834 US
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Contact
DUANE TRACY
Other 510(k) Applications for this Contact
Regulation Number
874.3620
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Classification Product Code
MIB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/18/1996
Decision Date
05/16/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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