The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Scleral Plug.
| Device ID | K831193 |
| 510k Number | K831193 |
| Device Name: | SCLERAL PLUG |
| Classification | Plug, Scleral |
| Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LXP |
| CFR Regulation Number | 886.4155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-12 |
| Decision Date | 1983-06-30 |