The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Schuster Disposable Balloon Probe.
| Device ID | K931175 |
| 510k Number | K931175 |
| Device Name: | SCHUSTER DISPOSABLE BALLOON PROBE |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
| Contact | Judy Griffith |
| Correspondent | Judy Griffith SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1994-04-01 |