The following data is part of a premarket notification filed by I-flow Llc with the FDA for On-q Painbuster, On-q C-bloc, Homepump Eclipse, Homepump C-series.
| Device ID | K131249 |
| 510k Number | K131249 |
| Device Name: | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | I-FLOW LLC 43 Discovery Suite 100 Irvine, CA 92618 |
| Contact | Shelly Harris |
| Correspondent | Shelly Harris I-FLOW LLC 43 Discovery Suite 100 Irvine, CA 92618 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2014-02-03 |
| Summary: | summary |