THE WAND

Syringe, Cartridge

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: K961648
• 510k Number: K961648
• Device Name: THE WAND
• Classification: Syringe, Cartridge
• 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: EJI
• CFR Regulation Number: 872.6770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-04-29
• Decision Date: 1996-07-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20618874000138	K961648	000
20618874000121	K961648	000
20618874000114	K961648	000
20618874000107	K961648	000
10618874000131	K961648	000
10618874000124	K961648	000
10618874000117	K961648	000
10618874000100	K961648	000