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FDA 510(k) Application Details - K992978
Device Classification Name
Keratome, Ac-Powered
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510(K) Number
K992978
Device Name
Keratome, Ac-Powered
Applicant
SURGISTAR, INC.
6068 CORTE DEL CEDRO
CARLSBAD, CA 92009 US
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Contact
JONATHAN WOODWARD
Other 510(k) Applications for this Contact
Regulation Number
886.4370
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Classification Product Code
HNO
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More FDA Info for this Product Code
Date Received
09/03/1999
Decision Date
11/16/1999
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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