The following data is part of a premarket notification filed by Eye Communications, Inc. with the FDA for Supervisor Sun Goggles(tm).
Device ID | K873405 |
510k Number | K873405 |
Device Name: | SUPERVISOR SUN GOGGLES(TM) |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | EYE COMMUNICATIONS, INC. 1209 S. SHAMROCK Monrovia, CA 91016 |
Contact | Bill Sardi |
Correspondent | Bill Sardi EYE COMMUNICATIONS, INC. 1209 S. SHAMROCK Monrovia, CA 91016 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-25 |
Decision Date | 1988-01-11 |