MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX

Stimulator, Peripheral Nerve, Implanted (pain Relief)

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 3550 Accessory Kit (contents) 3550-ox.

Pre-market Notification Details

• Device ID: K960631
• 510k Number: K960631
• Device Name: MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
• Classification: Stimulator, Peripheral Nerve, Implanted (pain Relief)
• Applicant: MEDTRONIC VASCULAR 800 53RD AVE., N.E. Minneapolis, MN 55421
• Contact: Jean Prather
• Correspondent: Jean Prather; MEDTRONIC VASCULAR 800 53RD AVE., N.E. Minneapolis, MN 55421
• Product Code: GZF
• CFR Regulation Number: 882.5870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-02-14
• Decision Date: 1996-05-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169953635	K960631	000
00643169887428	K960631	000
10681490077849	K960631	000