The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for New Sizes Sugita Clips.
| Device ID | K881911 |
| 510k Number | K881911 |
| Device Name: | NEW SIZES SUGITA CLIPS |
| Classification | Applier, Aneurysm Clip |
| Applicant | DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | John D Forster |
| Correspondent | John D Forster DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | HCI |
| CFR Regulation Number | 882.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-09 |
| Decision Date | 1988-06-06 |