The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Unidirectional Occluder.
| Device ID | K913230 |
| 510k Number | K913230 |
| Device Name: | UNIDIRECTIONAL OCCLUDER |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Craig Mullin |
| Correspondent | Craig Mullin WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1991-10-02 |