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 |