The following data is part of a premarket notification filed by Acces Intl. Eyewear with the FDA for Laurent Tardy.
Device ID | K903173 |
510k Number | K903173 |
Device Name: | LAURENT TARDY |
Classification | Frame, Spectacle |
Applicant | ACCES INTL. EYEWEAR 444 BUNKER RD. West Palm Beach, FL 33405 |
Contact | Stephan Laudicino |
Correspondent | Stephan Laudicino ACCES INTL. EYEWEAR 444 BUNKER RD. West Palm Beach, FL 33405 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-18 |
Decision Date | 1990-08-02 |