The following data is part of a premarket notification filed by Ipax, Inc. with the FDA for Blink External Eyelid Weight.
| Device ID | K971245 |
| 510k Number | K971245 |
| Device Name: | BLINK EXTERNAL EYELID WEIGHT |
| Classification | Weights, Eyelid, External |
| Applicant | IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Contact | Phil Pennell |
| Correspondent | Phil Pennell IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Product Code | MML |
| CFR Regulation Number | 886.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-03 |
| Decision Date | 1997-06-20 |
| Summary: | summary |