Dana Products, Inc.
South Barrington, IL, US
Dana Products, Inc. appears in FDA device records in South Barrington, IL. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Dana Products, Inc. between 2002 and 2014. The busiest year on record is 2011, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2010 | 2 |
| 2011 | 3 |
| 2013 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133267 | DANA REUSABLE TEST PACK | FRC | Substantially Equivalent | |
| K130135 | DANA REUSABLE BI TEST PACK | JOJ | Substantially Equivalent | |
| K120592 | DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS | JOJ | Substantially Equivalent | |
| K110253 | REUSABLE TEST PACK FOR DANA EMULATING INDICATORS | JOJ | Substantially Equivalent | |
| K103321 | DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES | FRC | Substantially Equivalent | |
| K100891 | DANA EMULATING INDICATOR | JOJ | Substantially Equivalent | |
| K102761 | DANA REUSABLE TEST PACK FOR STEAM STERILIZATION | JOJ | Substantially Equivalent | |
| K092944 | DANA REUSABLE TEST PACK FOR STEAM STERILIZATION | FRC | Substantially Equivalent | |
| K012195 | STEAM STERILIZATION INTERGRATOR | JOJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain