The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc. with the FDA for Young Prophy System, Ps Unit.
Device ID | K903284 |
510k Number | K903284 |
Device Name: | YOUNG PROPHY SYSTEM, PS UNIT |
Classification | Airbrush |
Applicant | YOUNG DENTAL MANUFACTURING CO 1, LLC. 13705 SHORELINE CT. EAST Earth City, MO 63045 |
Contact | Scott Richmond |
Correspondent | Scott Richmond YOUNG DENTAL MANUFACTURING CO 1, LLC. 13705 SHORELINE CT. EAST Earth City, MO 63045 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-22 |
Decision Date | 1990-12-17 |