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510(k) K962135

D.O.R.C. MICRODIATHERMY SYSTEM by Dutch Ophthalmic USA, Inc. — Product Code HQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1996
Date Received
June 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Ac-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

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