PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18

Stimulator, Spinal-cord, Implanted (pain Relief)

MEDAMICUS, INC.

The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Percutaneous Introducer Set, Model 042294 And Kit Model 3550-18.

Pre-market Notification Details

• Device ID: K013120
• 510k Number: K013120
• Device Name: PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
• Classification: Stimulator, Spinal-cord, Implanted (pain Relief)
• Applicant: MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447
• Contact: Dennis S Madison
• Correspondent: Dennis S Madison; MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447
• Product Code: GZB
• CFR Regulation Number: 882.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-09-18
• Decision Date: 2002-01-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994729989	K013120	000
20613994393054	K013120	000
00643169660076	K013120	000