The following data is part of a premarket notification filed by Scion International, Inc. with the FDA for Duoclipper Titanium Clips.
| Device ID | K973652 |
| 510k Number | K973652 |
| Device Name: | DUOCLIPPER TITANIUM CLIPS |
| Classification | Clip, Implantable |
| Applicant | SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami, FL 33126 |
| Contact | Stephen Chakoff |
| Correspondent | Stephen Chakoff SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami, FL 33126 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-25 |
| Decision Date | 1998-03-27 |