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FDA 510(k) Application Details - K961210
Device Classification Name
Implant, Malar
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510(K) Number
K961210
Device Name
Implant, Malar
Applicant
W.L. GORE & ASSOCIATES,INC
3750 WEST KILTIE LN.
FLAGSTAFF, AZ 86001 US
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Contact
JOHN W NICHOLSON
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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
03/28/1996
Decision Date
06/19/1996
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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