PROTECTOR NEEDLE SHEATH PROP
FDA 510(k) clearance K052725 · decided 2005-12-28
Clearance details
- K-number
- K052725
- Device name
- PROTECTOR NEEDLE SHEATH PROP
- Applicant
- Certol International, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-09-29
- Decision date
- 2005-12-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.