The following data is part of a premarket notification filed by Wr Medical Electronics Co. with the FDA for Hilger Dual-stim Nerve Stimulator.
Device ID | K063560 |
510k Number | K063560 |
Device Name: | HILGER DUAL-STIM NERVE STIMULATOR |
Classification | Stimulator, Nerve |
Applicant | WR MEDICAL ELECTRONICS CO. 800 LAVANGER LANE Stoughton, WI 53589 |
Contact | Gary Syring |
Correspondent | Gary Syring WR MEDICAL ELECTRONICS CO. 800 LAVANGER LANE Stoughton, WI 53589 |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-11-28 |
Decision Date | 2007-01-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00702173139050 | K063560 | 000 |
00702173139005 | K063560 | 000 |