The following data is part of a premarket notification filed by Precise Medical Products, Ltd. with the FDA for Smartinfuser Painpump, Model P49220 W/catheter Set; P49224n W/o Catheter Set.
| Device ID | K061409 |
| 510k Number | K061409 |
| Device Name: | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | PRECISE MEDICAL PRODUCTS, LTD. DORA ST. (INDUSTRIAL ZONE) Shlomi, IL 22832 |
| Contact | Ofer Shay |
| Correspondent | Ofer Shay PRECISE MEDICAL PRODUCTS, LTD. DORA ST. (INDUSTRIAL ZONE) Shlomi, IL 22832 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-22 |
| Decision Date | 2006-06-16 |
| Summary: | summary |