The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for 522 Intelligent Pump.
| Device ID | K882159 |
| 510k Number | K882159 |
| Device Name: | 522 INTELLIGENT PUMP |
| Classification | Pump, Infusion |
| Applicant | KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
| Contact | Joyce Williams |
| Correspondent | Joyce Williams KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-23 |
| Decision Date | 1988-08-24 |