The following data is part of a premarket notification filed by Hilco Corp. with the FDA for Talking Rap Shades.
Device ID | K940420 |
510k Number | K940420 |
Device Name: | TALKING RAP SHADES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | HILCO CORP. 232 SOUTH FOURTH ST. Philadelphia, PA 19106 |
Contact | Daniel K Astin |
Correspondent | Daniel K Astin HILCO CORP. 232 SOUTH FOURTH ST. Philadelphia, PA 19106 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-28 |
Decision Date | 1994-04-06 |