The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Operaid Surgical Drain.
| Device ID | K841721 |
| 510k Number | K841721 |
| Device Name: | OPERAID SURGICAL DRAIN |
| Classification | Sponge, Ophthalmic |
| 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 | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-25 |
| Decision Date | 1984-11-21 |