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510(k) K012821

D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM by Dutch Ophthalmic USA, Inc. — Product Code HRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2001
Date Received
August 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

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