The following data is part of a premarket notification filed by Miami Eye Technology, Inc. with the FDA for Clayman-parel Capsule Coupeur.
| Device ID | K841101 |
| 510k Number | K841101 |
| Device Name: | CLAYMAN-PAREL CAPSULE COUPEUR |
| Classification | Cystotome |
| Applicant | MIAMI EYE TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HNY |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-13 |
| Decision Date | 1984-05-16 |