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FDA 510(k) Application Details - K981063
Device Classification Name
Engine, Trephine, Accessories, Ac-Powered
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510(K) Number
K981063
Device Name
Engine, Trephine, Accessories, Ac-Powered
Applicant
LASER CENTER DEV. CORP.
1028 S. KIRKWOOD RD.
SUITE A
ST. LOUIS, MO 63122-7222 US
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Contact
FRANCIS E O'DONNELL, JR.
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Regulation Number
886.4070
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Classification Product Code
HRG
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More FDA Info for this Product Code
Date Received
03/23/1998
Decision Date
06/23/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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