The following data is part of a premarket notification filed by Sunrise International Business with the FDA for New Eyes Eyeglass Frame.
Device ID | K940250 |
510k Number | K940250 |
Device Name: | NEW EYES EYEGLASS FRAME |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | SUNRISE INTERNATIONAL BUSINESS 617 MANOMET COURT Schaumburg, IL 60173 |
Contact | David H Xu, Ph,d. |
Correspondent | David H Xu, Ph,d. SUNRISE INTERNATIONAL BUSINESS 617 MANOMET COURT Schaumburg, IL 60173 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-21 |
Decision Date | 1994-04-19 |