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 |