The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge Refill.
Device ID | K101617 |
510k Number | K101617 |
Device Name: | FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL |
Classification | Material, Impression |
Applicant | HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
Contact | Cheryl Zimmerman |
Correspondent | Cheryl Zimmerman HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-09 |
Decision Date | 2010-09-07 |
Summary: | summary |