The following data is part of a premarket notification filed by Novaspine Llc with the FDA for Novaspine Powered Suction Pump Pro-1.
| Device ID | K062456 |
| 510k Number | K062456 |
| Device Name: | NOVASPINE POWERED SUCTION PUMP PRO-1 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | NOVASPINE LLC P.O. BOX 205 Derby, CT 06418 |
| Contact | Dina L Weissman |
| Correspondent | Dina L Weissman NOVASPINE LLC P.O. BOX 205 Derby, CT 06418 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-23 |
| Decision Date | 2006-10-16 |
| Summary: | summary |