The following data is part of a premarket notification filed by Medical Technology Development Corp. with the FDA for Fyodorov Collagen Corneal Shield.
| Device ID | K862315 |
| 510k Number | K862315 |
| Device Name: | FYODOROV COLLAGEN CORNEAL SHIELD |
| Classification | Collagen Corneal Shield |
| Applicant | MEDICAL TECHNOLOGY DEVELOPMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
| Contact | Jose H Bedoya |
| Correspondent | Jose H Bedoya MEDICAL TECHNOLOGY DEVELOPMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
| Product Code | MOE |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-18 |
| Decision Date | 1987-01-07 |