The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Coated Tungsten Eyeshield.
| Device ID | K945515 |
| 510k Number | K945515 |
| Device Name: | COATED TUNGSTEN EYESHIELD |
| Classification | Shield, Eye, Radiological |
| Applicant | MEDTEC, INC. SALEM AVE. & 8TH ST. EAST HIGHWAY 10 Orange City, IA 51041 |
| Contact | Donald Riibe |
| Correspondent | Donald Riibe MEDTEC, INC. SALEM AVE. & 8TH ST. EAST HIGHWAY 10 Orange City, IA 51041 |
| Product Code | IWS |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1995-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439107782 | K945515 | 000 |
| 00841439107775 | K945515 | 000 |
| 00841439107768 | K945515 | 000 |