Submission Details
| 510(k) Number | K951917 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 24, 1995 |
| Decision Date | May 10, 1995 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K951917 is an FDA 510(k) clearance for the JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS, a Floss, Dental (Class I — General Controls, product code JES), submitted by Johnson & Johnson Consumer Products, Inc. (Skillman, US). The FDA issued a Cleared decision on May 10, 1995, 16 days after receiving the submission on April 24, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.6390.
| 510(k) Number | K951917 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 24, 1995 |
| Decision Date | May 10, 1995 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JES — Floss, Dental |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6390 |