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 |