The following data is part of a premarket notification filed by Pivotal Health Solutions with the FDA for Decompression Of Choice And Neuro Decompression Device.
| Device ID | K101889 |
| 510k Number | K101889 |
| Device Name: | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE |
| Classification | Equipment, Traction, Powered |
| Applicant | PIVOTAL HEALTH SOLUTIONS 1521 9TH AVE SE STE 3 Watertown, SD 57201 -3998 |
| Contact | Phillip Klein |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-07-07 |
| Decision Date | 2010-08-27 |
| Summary: | summary |