The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Sterile Air Syringe.
Device ID | K780550 |
510k Number | K780550 |
Device Name: | STERILE AIR SYRINGE |
Classification | Syringe, Piston |
Applicant | NATIONAL PATENT DEVELOPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-05 |
Decision Date | 1978-04-19 |