EAGLE

Syringe, Cartridge

AALBA DENT, INC.

The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Eagle.

Pre-market Notification Details

• Device ID: K950309
• 510k Number: K950309
• Device Name: EAGLE
• Classification: Syringe, Cartridge
• Applicant: AALBA DENT, INC. 400 WATT DR. Cordelia, CA 94534
• Contact: Vincent Benetti
• Correspondent: Vincent Benetti; AALBA DENT, INC. 400 WATT DR. Cordelia, CA 94534
• Product Code: EJI
• CFR Regulation Number: 872.6770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-01-25
• Decision Date: 1995-02-16