Submission Details
| 510(k) Number | K827847 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 04, 1982 |
| Decision Date | January 03, 1983 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
K827847 is an FDA 510(k) clearance for the ARGON FIBER OPTIC CATHETER, submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 3, 1983, 60 days after receiving the submission on November 4, 1982. This device falls under the Radiology review panel.
| 510(k) Number | K827847 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 04, 1982 |
| Decision Date | January 03, 1983 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | — |
| Device Class | — |