The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Stylekeeper Contact Lens Carrying Case.
| Device ID | K861643 |
| 510k Number | K861643 |
| Device Name: | STYLEKEEPER CONTACT LENS CARRYING CASE |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
| Contact | Marvin J Garrett |
| Correspondent | Marvin J Garrett ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
| Product Code | HPX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-30 |
| Decision Date | 1986-06-02 |