K792391 is an FDA 510(k) clearance for the COTTON ROLL COMPRESSION CAPS. This device is classified as a Cotton, Roll (Class I - General Controls, product code EFN).
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979, 10 days after receiving the submission on November 26, 1979.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6050.
| 510(k) Number | K792391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1979 |
| Decision Date | December 06, 1979 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EFN — Cotton, Roll |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6050 |