The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Comfort Control Syringe System.
Device ID | K002387 |
510k Number | K002387 |
Device Name: | COMFORT CONTROL SYRINGE SYSTEM |
Classification | Syringe, Cartridge |
Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
Contact | P. Jeffery Lehn |
Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
Product Code | EJI |
CFR Regulation Number | 872.6770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-04 |
Decision Date | 2000-09-28 |