PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES

Tray, Surgical

ANGIOSYSTEMS, INC.

The following data is part of a premarket notification filed by Angiosystems, Inc. with the FDA for Procedure Tray/for Various Ophthalmic Procedures.

Pre-market Notification Details

• Device ID: K905462
• 510k Number: K905462
• Device Name: PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES
• Classification: Tray, Surgical
• Applicant: ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021
• Contact: Alan P Schwartz
• Correspondent: Alan P Schwartz; ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021
• Product Code: LRP
• CFR Regulation Number: 878.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-12-05
• Decision Date: 1991-02-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816611023587	K905462	000
00816611023211	K905462	000
00816611023198	K905462	000
00816611023174	K905462	000
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