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FDA 510(k) Application Details - K982065
Device Classification Name
Elastomer, Silicone Block
More FDA Info for this Device
510(K) Number
K982065
Device Name
Elastomer, Silicone Block
Applicant
SPECIALTY SURGICAL PRODUCTS, INC.
302 NORTH FIRST ST.
HAMILTON, MT 59840 US
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Contact
T. JAN VARNER
Other 510(k) Applications for this Contact
Regulation Number
874.3620
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Classification Product Code
MIB
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More FDA Info for this Product Code
Date Received
06/12/1998
Decision Date
08/12/1998
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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