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 |