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510(k) K923531

OPTOSCALPEL I LASER SYSTEM by Optomed Corp. — Product Code HQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1993
Date Received
July 16, 1992
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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