The following data is part of a premarket notification filed by Carolina Medical, Inc. with the FDA for Infpump Infiltration Pump.
| Device ID | K050324 |
| 510k Number | K050324 |
| Device Name: | INFPUMP INFILTRATION PUMP |
| Classification | Pump, Infusion |
| Applicant | CAROLINA MEDICAL, INC. 157 INDUSTRIAL DR. King, NC 27030 |
| Contact | Leon Wilson |
| Correspondent | Leon Wilson CAROLINA MEDICAL, INC. 157 INDUSTRIAL DR. King, NC 27030 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B146EZP0 | K050324 | 000 |