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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Ac-Powered
510(k) Number K962135
Device Name D.O.R.C. MICRODIATHERMY SYSTEM
Applicant
Dutch Ophthalmic USA, Inc.
One Little River Rd.
P.O. Box 968
Kingston,  NH  03848
Applicant Contact MARK W FURLONG
Correspondent
Dutch Ophthalmic USA, Inc.
One Little River Rd.
P.O. Box 968
Kingston,  NH  03848
Correspondent Contact MARK W FURLONG
Regulation Number886.4115
Classification Product Code
HQO  
Date Received06/03/1996
Decision Date 08/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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