The following data is part of a premarket notification filed by Deroyal Surgical with the FDA for Deroyal Industries Disposable Laparoscopic Clip Applier With Implantable Titanium Clips.
| Device ID | K981239 |
| 510k Number | K981239 |
| Device Name: | DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS |
| Classification | Clip, Implantable |
| Applicant | DEROYAL SURGICAL 185 RICHARDSON WAY Maynardville, TN 37807 |
| Contact | Camille Matlock |
| Correspondent | Camille Matlock DEROYAL SURGICAL 185 RICHARDSON WAY Maynardville, TN 37807 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-03 |
| Decision Date | 1998-05-14 |
| Summary: | summary |