The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for Protected Needle With Or Without Iv Set.
| Device ID | K903809 |
| 510k Number | K903809 |
| Device Name: | PROTECTED NEEDLE WITH OR WITHOUT IV SET |
| Classification | Set, Administration, Intravascular |
| Applicant | KENDALL MCGAW LABORATORIES, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 |
| Contact | John G D'angelo |
| Correspondent | John G D'angelo KENDALL MCGAW LABORATORIES, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1990-10-03 |