The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Temporary Hemo Clip, 07-096-01/02 & Apply Forcep.
| Device ID | K862696 |
| 510k Number | K862696 |
| Device Name: | TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP |
| Classification | Applier, Hemostatic Clip |
| Applicant | DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | John Forster |
| Correspondent | John Forster DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | HBT |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-15 |
| Decision Date | 1986-07-30 |