THE WAND

Syringe, Piston

SPINTECH, INC.

The following data is part of a premarket notification filed by Spintech, Inc. with the FDA for The Wand.

Pre-market Notification Details

• Device ID: K992404
• 510k Number: K992404
• Device Name: THE WAND
• Classification: Syringe, Piston
• Applicant: SPINTECH, INC. 2000 M. ST. NW # 700 Washington, DC 20036
• Contact: Daniel J Manelli
• Correspondent: Daniel J Manelli; SPINTECH, INC. 2000 M. ST. NW # 700 Washington, DC 20036
• Product Code: FMF
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-07-19
• Decision Date: 2000-06-06
• Summary: summary