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510(k) K091064

NAVILAS LASER SYSTEM by Od-Os GmbH — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2009
Date Received
April 14, 2009
Clearance Type
Traditional
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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