The following data is part of a premarket notification filed by Medical Product Specialists with the FDA for Intravenous Extension Set.
| Device ID | K895367 |
| 510k Number | K895367 |
| Device Name: | INTRAVENOUS EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDICAL PRODUCT SPECIALISTS 16 TECHNOLOGY DRIVE, SUITE 145 Irvine, CA 92718 |
| Contact | Dan Hyun |
| Correspondent | Dan Hyun MEDICAL PRODUCT SPECIALISTS 16 TECHNOLOGY DRIVE, SUITE 145 Irvine, CA 92718 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-28 |
| Decision Date | 1989-10-06 |