The following data is part of a premarket notification filed by Intermedical, Inc. with the FDA for Im Collagen Shield.
| Device ID | K896449 |
| 510k Number | K896449 |
| Device Name: | IM COLLAGEN SHIELD |
| Classification | Collagen Corneal Shield |
| Applicant | INTERMEDICAL, INC. 1101 KNOLLWOOD DR. Safety Harbor, FL 34695 |
| Contact | Ron Theriot |
| Correspondent | Ron Theriot INTERMEDICAL, INC. 1101 KNOLLWOOD DR. Safety Harbor, FL 34695 |
| Product Code | MOE |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-09 |
| Decision Date | 1990-05-24 |