FDA 510(k) Application Details - K001772

Device Classification Name Laser, Ophthalmic

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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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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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