Submission Details
| 510(k) Number | K894018 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 1989 |
| Decision Date | September 12, 1989 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K894018 is an FDA 510(k) clearance for the RELIANCE(R) 6200 EXAMINATION CHAIR, a Chair, Ophthalmic, Ac-powered (Class I — General Controls, product code HME), submitted by Reliance Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 12, 1989, 98 days after receiving the submission on June 6, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1140.
| 510(k) Number | K894018 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 1989 |
| Decision Date | September 12, 1989 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HME — Chair, Ophthalmic, Ac-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.1140 |