The following data is part of a premarket notification filed by Novaspine Llc with the FDA for Simex Suction Pump, Models Ac20, Ac20k, Ac30, Dc20, Dc30 And Dc30s.
| Device ID | K061133 |
| 510k Number | K061133 |
| Device Name: | SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | NOVASPINE LLC PO BOX 969 Elmsford, NY 10523 |
| Contact | Hamid Khosrowshahi |
| Correspondent | Hamid Khosrowshahi NOVASPINE LLC PO BOX 969 Elmsford, NY 10523 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-24 |
| Decision Date | 2006-07-11 |
| Summary: | summary |