Submission Details
| 510(k) Number | K822267 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 1982 |
| Decision Date | October 13, 1982 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
K822267 is an FDA 510(k) clearance for the TRANSFORMER, submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1982, 76 days after receiving the submission on July 29, 1982. This device falls under the Gastroenterology & Urology review panel.
| 510(k) Number | K822267 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 1982 |
| Decision Date | October 13, 1982 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | — |
| Device Class | — |