The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Syringe, Insulin, Hypotip.
Device ID | K781154 |
510k Number | K781154 |
Device Name: | SYRINGE, INSULIN, HYPOTIP |
Classification | Syringe, Piston |
Applicant | NATIONAL PATENT DEVELOPMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-10 |
Decision Date | 1978-08-10 |