The following data is part of a premarket notification filed by Scion International, Inc. with the FDA for Scion Balloon Elevator.
Device ID | K973698 |
510k Number | K973698 |
Device Name: | SCION BALLOON ELEVATOR |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-26 |
Decision Date | 1998-03-31 |