The following data is part of a premarket notification filed by Halyard Health, Inc. with the FDA for Ministim Ms-ivb Peripheral Nerve Stimulator.
Device ID | K143095 |
510k Number | K143095 |
Device Name: | MiniStim MS-IVB Peripheral Nerve Stimulator |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | Halyard Health, Inc. 1400 Holcomb Bridge Road Roswell, GA 30076 |
Contact | Lindsey Hedlund |
Correspondent | Lindsey Hedlund Halyard Health, Inc. 1400 Holcomb Bridge Road Roswell, GA 30076 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-28 |
Decision Date | 2015-03-24 |
Summary: | summary |