Submission Details
| 510(k) Number | K827577 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 1982 |
| Decision Date | January 24, 1983 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
K827577 is an FDA 510(k) clearance for the VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER, submitted by Randwal Instrument Co., Inc. (Southbridge, US). The FDA issued a Cleared decision on January 24, 1983, 35 days after receiving the submission on December 20, 1982. This device falls under the Radiology review panel.
| 510(k) Number | K827577 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 1982 |
| Decision Date | January 24, 1983 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | — |
| Device Class | — |