The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Nerve Block Infusion Kit.
| Device ID | K984502 |
| 510k Number | K984502 |
| Device Name: | NERVE BLOCK INFUSION KIT |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-18 |
| Decision Date | 1999-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193494349834 | K984502 | 000 |
| 10193494135260 | K984502 | 000 |