The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Operaid Nucleus.
| Device ID | K841807 |
| 510k Number | K841807 |
| Device Name: | OPERAID NUCLEUS |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Contact | Eli Schachet |
| Correspondent | Eli Schachet JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-01 |
| Decision Date | 1984-11-21 |