The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for Infusion Pump.
| Device ID | K901065 |
| 510k Number | K901065 |
| Device Name: | INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
| Contact | Richard J Meader |
| Correspondent | Richard J Meader 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 | 1990-03-07 |
| Decision Date | 1990-08-21 |