K861338 is an FDA 510(k) clearance for the DENTAL COTTON ROLLS, STERILE AND NON-STERILE. This device is classified as a Cotton, Roll (Class I - General Controls, product code EFN).
Submitted by Intl. Verbandstoff-Fabrik Schaffhau (Switzlerland, CH). The FDA issued a Cleared decision on August 6, 1986, 121 days after receiving the submission on April 7, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6050.
| 510(k) Number | K861338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1986 |
| Decision Date | August 06, 1986 |
| Days to Decision | 121 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 |