K790555 is an FDA 510(k) clearance for the HEMO-WEDGE. This device is classified as a Instruments, Dental Hand (Class I - General Controls, product code DZN).
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980, 304 days after receiving the submission on March 19, 1979.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K790555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1979 |
| Decision Date | January 17, 1980 |
| Days to Decision | 304 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZN — Instruments, Dental Hand |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |