Submission Details
| 510(k) Number | K960334 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 24, 1996 |
| Decision Date | February 13, 1996 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
K960334 is an FDA 510(k) clearance for the CARDON PHYSICAL THERAPY TABLE MODEL R27116, a Table, Powered (Class I — General Controls, product code INQ), submitted by Cardon Rehabilitation Products, Inc. (Niagara Falls, US). The FDA issued a Cleared decision on February 13, 1996, 20 days after receiving the submission on January 24, 1996. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3760.
| 510(k) Number | K960334 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 24, 1996 |
| Decision Date | February 13, 1996 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INQ — Table, Powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.3760 |