K931205 is an FDA 510(k) clearance for the MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER. This device is classified as a System, Abortion, Vacuum (Class II - Special Controls, product code HHI).
Submitted by Baxter Healthcare Corp (Deerfield, US). The FDA issued a Cleared decision on March 15, 1994, 371 days after receiving the submission on March 9, 1993.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5070.
| 510(k) Number | K931205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1993 |
| Decision Date | March 15, 1994 |
| Days to Decision | 371 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHI — System, Abortion, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5070 |