The following data is part of a premarket notification filed by Pro Design Intl. As with the FDA for Spectable Frame - Prodesign Sun Club.
Device ID | K844658 |
510k Number | K844658 |
Device Name: | SPECTABLE FRAME - PRODESIGN SUN CLUB |
Classification | Frame, Spectacle |
Applicant | PRO DESIGN INTL. AS 20 WATERSIDE PLAZA APT 31-D New York, NY 10010 |
Contact | Lars Klitbo |
Correspondent | Lars Klitbo PRO DESIGN INTL. AS 20 WATERSIDE PLAZA APT 31-D New York, NY 10010 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-29 |
Decision Date | 1984-12-11 |