The following data is part of a premarket notification filed by Sorenson Medical, Inc. with the FDA for Palm Pump.
| Device ID | K002434 |
| 510k Number | K002434 |
| Device Name: | PALM PUMP |
| Classification | Pump, Infusion, Pca |
| 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 | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-09 |
| Decision Date | 2000-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193494000998 | K002434 | 000 |
| 00193494000813 | K002434 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PALM PUMP 76013044 2727559 Dead/Cancelled |
SORENSON DEVELOPMENT, INCORPORATED 2000-03-30 |