KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
FDA 510(k) clearance K060339 · decided 2006-04-28
Clearance details
- K-number
- K060339
- Device name
- KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
- Applicant
- Tyco Healthcare/Kendall
- Decision
- Substantially Equivalent
- Date received
- 2006-02-10
- Decision date
- 2006-04-28
- Days to decision
- 77 days
- Clearance type
- Special
- Product code
- NGT
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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