Submission Details
| 510(k) Number | K893598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 09, 1989 |
| Decision Date | October 10, 1989 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K893598 is an FDA 510(k) clearance for the HYDRAULIC FOOT OPERATED STOOL, a Chair, Surgical, Ac-powered (Class I — General Controls, product code GBB), submitted by Arthro-Medic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 10, 1989, 154 days after receiving the submission on May 9, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K893598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 09, 1989 |
| Decision Date | October 10, 1989 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GBB — Chair, Surgical, Ac-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4960 |