The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Homepump C-series And Homepump C-series One-step Kvo.
| Device ID | K991513 |
| 510k Number | K991513 |
| Device Name: | HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-30 |
| Decision Date | 1999-06-21 |
| Summary: | summary |