Source Production and Equipment Co., Inc.
Saint Rose, LA, US
Source Production and Equipment Co., Inc. appears in FDA device records in Saint Rose, LA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Source Production and Equipment Co., Inc. between 2006 and 2016. The busiest year on record is 2016, with 3. The most recent is 2016, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2009 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source | KXK | Substantially Equivalent | |
| K161396 | SPEC Model M23 | KXK | Substantially Equivalent | |
| K161395 | SPEC Model M13 | KXK | Substantially Equivalent | |
| K150895 | SPEC Model M16 | KXK | Substantially Equivalent | |
| K132969 | SPEC MODEL M15 | KXK | Substantially Equivalent | |
| K090366 | SPEC MODEL M-31 | KXK | Substantially Equivalent | |
| K052947 | SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE | JAQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1717-2009 | M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source. | Radioactive source broke during use. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain