MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
FDA 510(k) clearance K083765 · decided 2008-12-30
Clearance details
- K-number
- K083765
- Device name
- MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
- Applicant
- Medegen Medical Manufacturing Services
- Decision
- Substantially Equivalent
- Date received
- 2008-12-18
- Decision date
- 2008-12-30
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ontario, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.