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FDA 510(k) Application Details - K971479
Device Classification Name
Implant, Malar
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510(K) Number
K971479
Device Name
Implant, Malar
Applicant
ALLIED BIOMEDICAL CORP.
3850 RAMADA DR., SUITE C-2
PASO ROBLES, CA 93446 US
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Contact
GERALD HANSON
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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
04/23/1997
Decision Date
07/18/1997
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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