K883283 is an FDA 510(k) clearance for the DISPOSABLE AMNIOTOME. This device is classified as a Controller, Abortion Unit, Vacuum (Class II - Special Controls, product code HGG).
Submitted by Galenica Enterprises, Inc. (Quebec Canada J7e 4h7, CA). The FDA issued a Cleared decision on October 18, 1988, 75 days after receiving the submission on August 4, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5070.
| 510(k) Number | K883283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1988 |
| Decision Date | October 18, 1988 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HGG — Controller, Abortion Unit, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5070 |