The following data is part of a premarket notification filed by Wilson Hunt Intl./ltd. with the FDA for Champro/united Athletic.
Device ID | K950252 |
510k Number | K950252 |
Device Name: | CHAMPRO/UNITED ATHLETIC |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | WILSON HUNT INTL./LTD. 3600 JARVIS AVE. Skokie, IL 60076 |
Contact | Stephen P Fogel |
Correspondent | Stephen P Fogel WILSON HUNT INTL./LTD. 3600 JARVIS AVE. Skokie, IL 60076 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-23 |
Decision Date | 1995-02-27 |