K771070 is an FDA 510(k) clearance for the DRY HEAT STERILIZER. This device is classified as a Sterilizer, Dry Heat (Class II - Special Controls, product code KMH).
Submitted by Cpac, Inc. (Walker, US). The FDA issued a Cleared decision on July 14, 1977, 30 days after receiving the submission on June 14, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6870.
| 510(k) Number | K771070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1977 |
| Decision Date | July 14, 1977 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KMH — Sterilizer, Dry Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6870 |