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510(k) K113857

SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE by Synergetics, Inc. — Product Code HQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2012
Date Received
December 30, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
Review Panel
OP
Submission Type

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