The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for Secondary Iv Set With Protected Needle.
| Device ID | K895109 |
| 510k Number | K895109 |
| Device Name: | SECONDARY IV SET WITH PROTECTED NEEDLE |
| Classification | Set, Administration, Intravascular |
| Applicant | KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
| Contact | Richard Meader |
| Correspondent | Richard Meader KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-15 |
| Decision Date | 1989-09-27 |