The following data is part of a premarket notification filed by Atlantic Optical Co., Inc. with the FDA for Sunglasses/various Collections.
| Device ID | K941555 |
| 510k Number | K941555 |
| Device Name: | SUNGLASSES/VARIOUS COLLECTIONS |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | ATLANTIC OPTICAL CO., INC. 20801 NORDHOFF ST. P.O. BOX 3519 Chatsworth, CA 91313 |
| Contact | Mel Hoffman |
| Correspondent | Mel Hoffman ATLANTIC OPTICAL CO., INC. 20801 NORDHOFF ST. P.O. BOX 3519 Chatsworth, CA 91313 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-31 |
| Decision Date | 1994-07-12 |