E-Z-FLATE— 510(k) K930581
Substantially EquivalentE-Z-Em, Inc.
FDA 510(k) clearance K930581 for E-Z-FLATE, Substantially Equivalent on 1994-07-01. 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
- Traditional
- Location
- Westbury, NY, US
Recent devices under product code FCX
view allMore clearances from E-Z-Em, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.