The following data is part of a premarket notification filed by Sorenson Medical, Inc. with the FDA for 30 Pump, Continuous Low Flow, 200 Pump, Intermittent With Kvo Or Continuous, Pca Pump, Pain Management, Pcea Pump, Epidu.
| Device ID | K991363 |
| 510k Number | K991363 |
| Device Name: | 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU |
| Classification | Pump, Infusion |
| Applicant | SORENSON MEDICAL, INC. 1375 WEST 8040 SOUTH West Jordan, UT 84088 -8320 |
| Contact | R. Douglas Jacob |
| Correspondent | R. Douglas Jacob SORENSON MEDICAL, INC. 1375 WEST 8040 SOUTH West Jordan, UT 84088 -8320 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-20 |
| Decision Date | 1999-05-13 |