The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Stimulus/dissection Instruments.
| Device ID | K090838 |
| 510k Number | K090838 |
| Device Name: | STIMULUS/DISSECTION INSTRUMENTS |
| Classification | Stimulator, Nerve |
| Applicant | AXON SYSTEMS, INC. 80-5 DAVIDS DRIVE Hauppauge, NY 11788 |
| Contact | Howard Bailin |
| Correspondent | Howard Bailin AXON SYSTEMS, INC. 80-5 DAVIDS DRIVE Hauppauge, NY 11788 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-27 |
| Decision Date | 2009-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994870803 | K090838 | 000 |
| 00613994720016 | K090838 | 000 |
| 00613994513960 | K090838 | 000 |
| 00613994513953 | K090838 | 000 |
| 00613994513946 | K090838 | 000 |
| 00613994487049 | K090838 | 000 |
| 00613994487032 | K090838 | 000 |
| 00613994487025 | K090838 | 000 |