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FDA 510(k) Application Details - K990075
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K990075
Device Name
Laser, Ophthalmic
Applicant
LIGHT-MED (USA), INC.
110P VIA ESTRADA
LAGUNA HILLS, CA 92653 US
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Contact
THOMAS V KEELEY
Other 510(k) Applications for this Contact
Regulation Number
886.4390
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Classification Product Code
HQF
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More FDA Info for this Product Code
Date Received
01/11/1999
Decision Date
03/30/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K990075
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