NEUROTUBE

Cuff, Nerve

NEUROREGEN, L.L.C.

The following data is part of a premarket notification filed by Neuroregen, L.l.c. with the FDA for Neurotube.

Pre-market Notification Details

• Device ID: K983007
• 510k Number: K983007
• Device Name: NEUROTUBE
• Classification: Cuff, Nerve
• Applicant: NEUROREGEN, L.L.C. 43 N. BONDS ST. Bel Air, MD 21014
• Contact: John E Barham
• Correspondent: John E Barham; NEUROREGEN, L.L.C. 43 N. BONDS ST. Bel Air, MD 21014
• Product Code: JXI
• CFR Regulation Number: 882.5275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-08-28
• Decision Date: 1999-03-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00844735006193	K983007	000
00844735006186	K983007	000