The following data is part of a premarket notification filed by Pemlab Corp. with the FDA for Infusion Pump.
| Device ID | K882830 |
| 510k Number | K882830 |
| Device Name: | INFUSION PUMP |
| Classification | Pump, Infusion, Analytical Sampling |
| Applicant | PEMLAB CORP. 3770 TANSY ST. San Diego, CA 92121 |
| Contact | Barney Parker |
| Correspondent | Barney Parker PEMLAB CORP. 3770 TANSY ST. San Diego, CA 92121 |
| Product Code | LZF |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-08 |
| Decision Date | 1988-12-30 |