Submission Details
| 510(k) Number | K915299 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 1991 |
| Decision Date | January 31, 1992 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
K915299 is an FDA 510(k) clearance for the COGAN CORP KITS OF DENTAL HAND INSTRUMENTS, a Attachment, Precision, All (Class I — General Controls, product code EGG), submitted by Cogan Corp. (Portland, US). The FDA issued a Cleared decision on January 31, 1992, 73 days after receiving the submission on November 19, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.
| 510(k) Number | K915299 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 1991 |
| Decision Date | January 31, 1992 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EGG — Attachment, Precision, All |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.3165 |