CMI VACUUM PUMP
Device Facts
| Record ID | K914552 |
|---|---|
| Device Name | CMI VACUUM PUMP |
| Applicant | Columbia Medical & Surgical, Inc. |
| Product Code | HDA · Obstetrics/Gynecology |
| Decision Date | Sep 7, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.
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.
