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FDA 510(k) Application Details - K983756
Device Classification Name
Implant, Malar
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510(K) Number
K983756
Device Name
Implant, Malar
Applicant
SURGICAL TECHNOLOGY LABORATORIES, INC.
1588 EAST 40TH ST.
CLEVELAND, OH 44103 US
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Contact
RICHARD T NOCK
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
10/22/1998
Decision Date
11/20/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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