Submission Details
| 510(k) Number | K891609 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 20, 1989 |
| Decision Date | April 06, 1989 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K891609 is an FDA 510(k) clearance for the CARRETTE 3 WHEELED MOTORIZED CART, a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on April 6, 1989, 17 days after receiving the submission on March 20, 1989. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K891609 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 20, 1989 |
| Decision Date | April 06, 1989 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | INI — Vehicle, Motorized 3-wheeled |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.3800 |