The following data is part of a premarket notification filed by Sentinal Importing Corp. with the FDA for Barakka, Inferno, Sterling, And/or One.
| Device ID | K970944 |
| 510k Number | K970944 |
| Device Name: | BARAKKA, INFERNO, STERLING, AND/OR ONE |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SENTINAL IMPORTING CORP. 125 CHARLES ST. North Vancouver, B.c., CA V7h 1s1 |
| Contact | Brent Martin |
| Correspondent | Brent Martin SENTINAL IMPORTING CORP. 125 CHARLES ST. North Vancouver, B.c., CA V7h 1s1 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-13 |
| Decision Date | 1997-05-06 |