K935067 is an FDA 510(k) clearance for the AQUAPLAST. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Wfr/Aquaplast Corp. (Wyckoff, US). The FDA issued a Cleared decision on May 26, 1994, 218 days after receiving the submission on October 20, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K935067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1993 |
| Decision Date | May 26, 1994 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IYE — Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |