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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, contact, polymethylmethacrylate, diagnostic
510(k) Number K050623
Device Name VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
Applicant
VOLK OPTICAL, INC.
15825 SHADY GROVE RD.
SUITE 30
ROCKVILLE,  MD  20850
Applicant Contact RICHARD E LIPPMAN
Correspondent
VOLK OPTICAL, INC.
15825 SHADY GROVE RD.
SUITE 30
ROCKVILLE,  MD  20850
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.1385
Classification Product Code
HJK  
Date Received03/10/2005
Decision Date 03/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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