The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultra-blaster.
Device ID | K980726 |
510k Number | K980726 |
Device Name: | ULTRA-BLASTER |
Classification | Airbrush |
Applicant | ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
Contact | Chester Mccoy |
Correspondent | Chester Mccoy ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-24 |
Decision Date | 1998-05-12 |