K982658 is an FDA 510(k) clearance for the KSEA ENDOSCOPES FOR DENTAL PROCEDURES. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on October 15, 1998, 77 days after receiving the submission on July 30, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K982658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1998 |
| Decision Date | October 15, 1998 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |