The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for 1.2 Micron Filter With Iv Set.
| Device ID | K896292 |
| 510k Number | K896292 |
| Device Name: | 1.2 MICRON FILTER WITH IV SET |
| Classification | Filter, Infusion Line |
| 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 | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-31 |
| Decision Date | 1989-12-08 |