The following data is part of a premarket notification filed by Stockert Gmbh with the FDA for Stimuplex Hns-11.
Device ID | K003983 |
510k Number | K003983 |
Device Name: | STIMUPLEX HNS-11 |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | STOCKERT GMBH BOTZINGER STRABE 72 Freiburg, DE D-79111 |
Contact | Dominika Schuler |
Correspondent | Dominika Schuler STOCKERT GMBH BOTZINGER STRABE 72 Freiburg, DE D-79111 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-26 |
Decision Date | 2001-06-06 |