TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
Device Facts
| Record ID | K963505 |
|---|---|
| Device Name | TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM |
| Applicant | Tenet Medical Engineering |
| Product Code | HHP · Obstetrics/Gynecology |
| Decision Date | Feb 14, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.4900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
