The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Mark Iv Syringe.
Device ID | K801483 |
510k Number | K801483 |
Device Name: | MARK IV SYRINGE |
Classification | Syringe, Periodontic, Endodontic, Irrigating |
Applicant | NATIONAL PATENT DEVELOPMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EIC |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-16 |
Decision Date | 1980-07-21 |