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510(k) K091581

SUPRA 577.Y LASER by Quantel Medical — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2009
Date Received
June 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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