EMPOWER TRANSFER SET, (CAT. NO. 7725)— 510(k) K041178
Substantially EquivalentE-Z-Em, Inc.
FDA 510(k) clearance K041178 for EMPOWER TRANSFER SET, (CAT. NO. 7725), Substantially Equivalent on 2004-07-16. Applicant: E-Z-Em, Inc.. Device class: 2.
Clearance details
- Applicant
- E-Z-Em, Inc.
- Product code
- Code FPK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westbury, NY, US
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