Submission Details
| 510(k) Number | K822013 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 08, 1982 |
| Decision Date | July 28, 1982 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K822013 is an FDA 510(k) clearance for the NAGASHIMA SN AUTOMATIC TREATMENT CHAIR, a Chair, Surgical, Ac-powered (Class I — General Controls, product code GBB), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1982, 20 days after receiving the submission on July 8, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K822013 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 08, 1982 |
| Decision Date | July 28, 1982 |
| Days to Decision | 20 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 |