The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Resubmitted Juniper T.m. Joint Distraction Forceps.
| Device ID | K881757 |
| 510k Number | K881757 |
| Device Name: | RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS |
| Classification | Stimulator, Nerve |
| Applicant | DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | Forster |
| Correspondent | Forster DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-25 |
| Decision Date | 1988-07-15 |