The following data is part of a premarket notification filed by Therapeutic Technologies, Inc. with the FDA for Fuorecam.
Device ID | K093705 |
510k Number | K093705 |
Device Name: | FUORECAM |
Classification | Laser, Fluorescence Caries Detection |
Applicant | THERAPEUTIC TECHNOLOGIES, INC. 351 W.10TH ST., STE. 222 Indianapolis, IN 46202 -4119 |
Contact | Bart Collins |
Correspondent | Bart Collins THERAPEUTIC TECHNOLOGIES, INC. 351 W.10TH ST., STE. 222 Indianapolis, IN 46202 -4119 |
Product Code | NBL |
CFR Regulation Number | 872.1745 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-01 |
Decision Date | 2010-04-23 |
Summary: | summary |