K781221 is an FDA 510(k) clearance for the DILUTION KIT, THERMAL, COLD PAC. This device is classified as a Trocar (Class II - Special Controls, product code DRC).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on August 23, 1978, 37 days after receiving the submission on July 17, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K781221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1978 |
| Decision Date | August 23, 1978 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRC — Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |