The following data is part of a premarket notification filed by I-flow Corp. with the FDA for I-flow Elastomeric Pump (on-q, Painbuster, C-block, Homepump, Easypump).
| Device ID | K052117 |
| 510k Number | K052117 |
| Device Name: | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Contact | Shane Noehre |
| Correspondent | Shane Noehre I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-04 |
| Decision Date | 2005-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193494442795 | K052117 | 000 |
| 10193494135758 | K052117 | 000 |
| 10193494135741 | K052117 | 000 |
| 10193494135734 | K052117 | 000 |
| 10193494135727 | K052117 | 000 |
| 10193494135567 | K052117 | 000 |
| 10193494135550 | K052117 | 000 |
| 10193494135543 | K052117 | 000 |
| 10193494135536 | K052117 | 000 |
| 10193494135529 | K052117 | 000 |
| 10193494135512 | K052117 | 000 |
| 10193494135499 | K052117 | 000 |
| 10193494135482 | K052117 | 000 |
| 10193494348851 | K052117 | 000 |
| 10193494348868 | K052117 | 000 |
| 10193494348875 | K052117 | 000 |
| 10193494442788 | K052117 | 000 |
| 10193494442771 | K052117 | 000 |
| 10193494442764 | K052117 | 000 |
| 10193494442740 | K052117 | 000 |
| 10193494442733 | K052117 | 000 |
| 10193494442726 | K052117 | 000 |
| 10193494433892 | K052117 | 000 |
| 10193494348998 | K052117 | 000 |
| 10193494348912 | K052117 | 000 |
| 10193494348905 | K052117 | 000 |
| 10193494348899 | K052117 | 000 |
| 10193494348882 | K052117 | 000 |
| 10193494135475 | K052117 | 000 |