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FDA 510(k) Application Details - K955368
Device Classification Name
Elastomer, Silicone Block
More FDA Info for this Device
510(K) Number
K955368
Device Name
Elastomer, Silicone Block
Applicant
ALLIED BIOMEDICAL CORP.
118-D SPRINGHALL DR.
GOOSE CREEK, SC 29445 US
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Contact
GERALD HANSON
Other 510(k) Applications for this Contact
Regulation Number
874.3620
More FDA Info for this Regulation Number
Classification Product Code
MIB
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More FDA Info for this Product Code
Date Received
11/22/1995
Decision Date
02/08/1996
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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