SPOON

Instrument, Surgical, Disposable

EURO-MED INTL.

The following data is part of a premarket notification filed by Euro-med Intl. with the FDA for Spoon.

Pre-market Notification Details

• Device ID: K854894
• 510k Number: K854894
• Device Name: SPOON
• Classification: Instrument, Surgical, Disposable
• Applicant: EURO-MED INTL. ADVANCED BIOSEARCH ASSOCIATES 3880 BLACKHAWK ROAD Danville, CA 94526
• Contact: Donald Holsten
• Correspondent: Donald Holsten; EURO-MED INTL. ADVANCED BIOSEARCH ASSOCIATES 3880 BLACKHAWK ROAD Danville, CA 94526
• Product Code: KDC
• CFR Regulation Number: 878.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-12-06
• Decision Date: 1986-05-02