The following data is part of a premarket notification filed by Neuromechanical Innovations, Llc with the FDA for Impulse-adjusting Instrument, Cbp Adjusting Instrument, Neuromechanical Adjusting Instrument, Models 2003.
| Device ID | K023462 |
| 510k Number | K023462 |
| Device Name: | IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003 |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | NEUROMECHANICAL INNOVATIONS, LLC 11011 S. 48TH ST. SUITE 205 Phoenix, AZ 85044 |
| Contact | Christopher J Colloca |
| Correspondent | Christopher J Colloca NEUROMECHANICAL INNOVATIONS, LLC 11011 S. 48TH ST. SUITE 205 Phoenix, AZ 85044 |
| Product Code | LXM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2003-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011416470 | K023462 | 000 |
| 00860011416463 | K023462 | 000 |
| 00860011416401 | K023462 | 000 |
| 00086001141645 | K023462 | 000 |
| 00860011416487 | K023462 | 000 |