The following data is part of a premarket notification filed by Scion International, Inc. with the FDA for Scion Saphenous Vein Harvesting System.
| Device ID | K963006 |
| 510k Number | K963006 |
| Device Name: | SCION SAPHENOUS VEIN HARVESTING SYSTEM |
| Classification | Retractor |
| Applicant | SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami, FL 33126 |
| Contact | Frank Goldfarb |
| Correspondent | Frank Goldfarb SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami, FL 33126 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-02 |
| Decision Date | 1996-09-20 |