K862600 is an FDA 510(k) clearance for the SITZ BATH. This device is classified as a Bath, Sitz, Nonpowered (Class I - General Controls, product code KTC).
Submitted by W. C. Green, D.D.S. (Valdosta, US). The FDA issued a Cleared decision on July 18, 1986, 10 days after receiving the submission on July 8, 1986.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5125.
| 510(k) Number | K862600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 1986 |
| Decision Date | July 18, 1986 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | KTC — Bath, Sitz, Nonpowered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5125 |