K893807 is an FDA 510(k) clearance for the MODEL 0183010, PEARL MEDICAL EXAM LIGHT. This device is classified as a Device, Medical Examination, Ac Powered (Class I - General Controls, product code KZF).
Submitted by Burton Medical Products Corp. (Van Nuys, US). The FDA issued a Cleared decision on August 15, 1989, 85 days after receiving the submission on May 22, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6320.
| 510(k) Number | K893807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1989 |
| Decision Date | August 15, 1989 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KZF — Device, Medical Examination, Ac Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6320 |