K833497 is an FDA 510(k) clearance for the COOPER MEDICAL MODEL 770. This device is classified as a Laser, Neurosurgical, Argon (Class III - Premarket Approval, product code LLF).
Submitted by Cooper Medical Corp. (Walker, US). The FDA issued a Cleared decision on April 17, 1984, 189 days after receiving the submission on October 11, 1983.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K833497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1983 |
| Decision Date | April 17, 1984 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | LLF — Laser, Neurosurgical, Argon |
| Device Class | Class III - Premarket Approval |