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FDA 510(k) Application Details - K960362
Device Classification Name
Implant, Malar
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510(K) Number
K960362
Device Name
Implant, Malar
Applicant
CERAMED CORP.
12860 WEST CEDAR DR., STE. 110
LAKEWOOD, CO 80228 US
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Contact
BARBARA A WATSON
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LZK
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More FDA Info for this Product Code
Date Received
01/25/1996
Decision Date
03/20/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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