The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Cls-2000 Unit.
Device ID | K024133 |
510k Number | K024133 |
Device Name: | CLS-2000 UNIT |
Classification | Sterilizer, Steam |
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 | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-16 |
Decision Date | 2003-10-01 |
Summary: | summary |