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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryophthalmic, Ac-Powered
510(k) Number K012821
Device Name D.O.R.C. CRYOSTAR CRYOSURGICAL 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 Number886.4170
Classification Product Code
HRN  
Date Received08/23/2001
Decision Date 10/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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