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 |