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
00816611023723	K905462	000
00816611023396	K905462	000
00816611023372	K905462	000
00816611023358	K905462	000
00816611023334	K905462	000
00816611023310	K905462	000
00816611023297	K905462	000
00816611023273	K905462	000
00816611023259	K905462	000
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00816611023174	K905462	000
00816611023150	K905462	000
00816611023419	K905462	000
00816611023433	K905462	000
00816611023709	K905462	000
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00816611023624	K905462	000
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00816611025741	K905462	000
10816611025755	K905462	000
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