BOTTLE COLLECTION SET
Device Facts
| Record ID | K945179 |
|---|---|
| Device Name | BOTTLE COLLECTION SET |
| Applicant | Medgyn Products, Inc. |
| Product Code | HGF · Obstetrics/Gynecology |
| Decision Date | Jan 26, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5070 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.
