K871816 is an FDA 510(k) clearance for the STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM. This device is classified as a Light, Fiber Optic, Dental (Class I - General Controls, product code EAY).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on August 3, 1987, 84 days after receiving the submission on May 11, 1987.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4620.
| 510(k) Number | K871816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1987 |
| Decision Date | August 03, 1987 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EAY — Light, Fiber Optic, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4620 |