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510(k) K033950

DORC VITRECTOMY LENSES, MODEL 1284 SERIES by Dutch Ophthalmic Research Center (D.O.R.C.) — Product Code HJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
December 22, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class
Class II
Regulation Number
886.1385
Review Panel
OP
Submission Type

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