The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Eye Sponge Or Spear.
| Device ID | K834356 |
| 510k Number | K834356 |
| Device Name: | EYE SPONGE OR SPEAR |
| Classification | Sponge, Ophthalmic |
| Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-13 |
| Decision Date | 1984-03-16 |