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510(k) K081946

SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR by Quantel Medical — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2009
Date Received
July 8, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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