K772365 is an FDA 510(k) clearance for the THERMOMETER SHEATHS. This device is classified as a Thermometer, Clinical Mercury (Class II - Special Controls, product code FLK).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1978, 30 days after receiving the submission on December 27, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2920.
| 510(k) Number | K772365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1977 |
| Decision Date | January 26, 1978 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FLK — Thermometer, Clinical Mercury |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2920 |