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510(k) K943125

QUADRASPHERIC FUNDUS LENS by Volk Optical, Inc. — Product Code HJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1994
Date Received
June 29, 1994
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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  • K023221 — CONTACT LASER & DIAGNOSTIC LENSES (October 11, 2002)

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  • K050623 — VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK (March 28, 2005)
  • K033950 — DORC VITRECTOMY LENSES, MODEL 1284 SERIES (February 20, 2004)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • K023221 — CONTACT LASER & DIAGNOSTIC LENSES (October 11, 2002)