K781766 is an FDA 510(k) clearance for the UTERINE SOUND, BURNETT DISPOSABLE. This device is classified as a Sound, Uterine (Class I - General Controls, product code HHM).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978, 52 days after receiving the submission on October 16, 1978.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K781766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1978 |
| Decision Date | December 07, 1978 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHM — Sound, Uterine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.4530 |