The following data is part of a premarket notification filed by Norcon, Inc. with the FDA for Sunglasses, Imported.
| Device ID | K883771 |
| 510k Number | K883771 |
| Device Name: | SUNGLASSES, IMPORTED |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | NORCON, INC. 15960 MUIRFIELD CT. Ft. Myers, FL 33908 |
| Contact | G Milley |
| Correspondent | G Milley NORCON, INC. 15960 MUIRFIELD CT. Ft. Myers, FL 33908 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1988-09-15 |