The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Modification Of Surgical Eyeshield Mask.
| Device ID | K934085 |
| 510k Number | K934085 |
| Device Name: | MODIFICATION OF SURGICAL EYESHIELD MASK |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Contact | Robert T Bayer |
| Correspondent | Robert T Bayer AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-20 |
| Decision Date | 1993-11-12 |