The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc. with the FDA for Young D'granulator.
Device ID | K932255 |
510k Number | K932255 |
Device Name: | YOUNG D'GRANULATOR |
Classification | Handpiece, Rotary Bone Cutting |
Applicant | YOUNG DENTAL MANUFACTURING CO 1, LLC. 13705 SHORELINE CT. EAST Earth City, MO 63045 |
Contact | Jeff Kopp |
Correspondent | Jeff Kopp YOUNG DENTAL MANUFACTURING CO 1, LLC. 13705 SHORELINE CT. EAST Earth City, MO 63045 |
Product Code | KMW |
CFR Regulation Number | 872.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-10 |
Decision Date | 1994-04-15 |