The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Rootman Orbital Surgery Instrument Set.
| Device ID | K842697 |
| 510k Number | K842697 |
| Device Name: | ROOTMAN ORBITAL SURGERY INSTRUMENT SET |
| Classification | Forceps, Ophthalmic |
| Applicant | DOWNS SURGICAL LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-11 |
| Decision Date | 1984-08-07 |