PROTOCO2L INSUFFLATOR MODEL 6400— 510(k) K013219
Substantially EquivalentE-Z-Em, Inc.
FDA 510(k) clearance K013219 for PROTOCO2L INSUFFLATOR MODEL 6400, Substantially Equivalent on 2002-02-19. Applicant: E-Z-Em, Inc.. Device class: 2.
Clearance details
- Applicant
- E-Z-Em, Inc.
- Product code
- Code FCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Westbury, NY, US
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