PACKAGING TRAY AND COMPONENTS
FDA 510(k) clearance K040707 · decided 2004-04-16
Clearance details
- K-number
- K040707
- Device name
- PACKAGING TRAY AND COMPONENTS
- Applicant
- Vygon Us, LLC
- Decision
- Substantially Equivalent
- Date received
- 2004-03-18
- Decision date
- 2004-04-16
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Norristown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.