PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400— 510(k) K030854
Substantially EquivalentE-Z-Em, Inc.
FDA 510(k) clearance K030854 for PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400, Substantially Equivalent on 2003-04-16. Applicant: E-Z-Em, Inc..
Clearance details
- Applicant
- E-Z-Em, Inc.
- Product code
- Code FCX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Westbury, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.