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FDA 510(k) Application Details - K070776
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K070776
Device Name
Laser, Ophthalmic
Applicant
QUANTEL MEDICAL
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS, NJ 07604 US
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Contact
GEORGE MYERS
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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
03/21/2007
Decision Date
04/24/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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