CUSTODIOL
FDA 510(k) clearance K032794 · decided 2004-04-05
Clearance details
- K-number
- K032794
- Device name
- CUSTODIOL
- Applicant
- Dr. Franz Kohler Chemie GmbH
- Decision
- Substantially Equivalent
- Date received
- 2003-09-08
- Decision date
- 2004-04-05
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- MSB
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Brookeville, MD, US
- Third-party review
- No
- Expedited review
- No
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| CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS (K991594) | Sangstat Medical Corp. | 1999-08-05 |
Recalls involving this device
No recalls on record reference this clearance.