ENDOGATER AVANTAGE CO2 INSUFFLATOR— 510(k) K113310
Substantially EquivalentByrne Medical, Inc.
FDA 510(k) clearance K113310 for ENDOGATER AVANTAGE CO2 INSUFFLATOR, Substantially Equivalent on 2012-06-20. Applicant: Byrne Medical, Inc..
Clearance details
- Applicant
- Byrne Medical, Inc.
- Product code
- Code FCX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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