The following data is part of a premarket notification filed by Denver Biomedicals, Inc. with the FDA for Crouch Corneal Protector.
| Device ID | K811577 |
| 510k Number | K811577 |
| Device Name: | CROUCH CORNEAL PROTECTOR |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | DENVER BIOMEDICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-05 |
| Decision Date | 1981-08-07 |