AUTOPEN

Syringe, Piston

ULSTER SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Autopen.

Pre-market Notification Details

• Device ID: K895890
• 510k Number: K895890
• Device Name: AUTOPEN
• Classification: Syringe, Piston
• Applicant: ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528
• Contact: F Cunningham
• Correspondent: F Cunningham; ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528
• Product Code: FMF
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-10-05
• Decision Date: 1990-02-16