The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Stv Pro 2.
Device ID | K033419 |
510k Number | K033419 |
Device Name: | STV PRO 2 |
Classification | Unit, Operative Dental |
Applicant | TROPHY RADIOLOGIE 4 RUE F. PELLOUTIER CROISSY-BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
Contact | Marie-pierre Labat-camy |
Correspondent | Marie-pierre Labat-camy TROPHY RADIOLOGIE 4 RUE F. PELLOUTIER CROISSY-BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-27 |
Decision Date | 2004-02-02 |