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FDA 510(k) Application Details - K001772
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K001772
Device Name
Laser, Ophthalmic
Applicant
TARACAN PTY. LTD.
258 HALIFAX ST.
ADELAIDE, SOUTH AUSTRALIA 5000 AU
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Contact
KEITH DEGENHARDT
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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
06/12/2000
Decision Date
07/06/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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