The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Horizon Pump Y-type Blood Set.
| Device ID | K922637 |
| 510k Number | K922637 |
| Device Name: | HORIZON PUMP Y-TYPE BLOOD SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 -9791 |
| Contact | Diane Gerst |
| Correspondent | Diane Gerst MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 -9791 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-04 |
| Decision Date | 1993-06-04 |