VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D

Lens, Contact, Polymethylmethacrylate, Diagnostic

VOLK OPTICAL, INC.

The following data is part of a premarket notification filed by Volk Optical, Inc. with the FDA for Volk Disposable Vitrectomy Lenses, Models Volk Flat Ssv D, Volk Afx Ssv D, Volk 45 Prism Ssv D.

Pre-market Notification Details

• Device ID: K050623
• 510k Number: K050623
• Device Name: VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
• Classification: Lens, Contact, Polymethylmethacrylate, Diagnostic
• Applicant: VOLK OPTICAL, INC. 15825 SHADY GROVE RD. SUITE 30 Rockville, MD 20850
• Contact: Richard E Lippman
• Correspondent: Richard E Lippman; VOLK OPTICAL, INC. 15825 SHADY GROVE RD. SUITE 30 Rockville, MD 20850
• Product Code: HJK
• CFR Regulation Number: 886.1385 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-10
• Decision Date: 2005-03-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10811608014675	K050623	000