EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN— 510(k) K853296
Substantially EquivalentParexel Intl. Corp.
FDA 510(k) clearance K853296 for EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN, Substantially Equivalent on 1985-08-15. Applicant: Parexel Intl. Corp.. Device class: 2.
Clearance details
- Applicant
- Parexel Intl. Corp.
- Product code
- Code BYY
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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