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 |