FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
K Number: K063350
·
Decision Feb 1, 2008
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
44
Review Days
452
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Basic Information
- Device Name
- DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
- K Number
- K063350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PAJUNK GmbH Medizintechnologie
- Date Received
- November 6, 2006
- Decision Date
- February 1, 2008
- Product Code
- BSP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | FDA class 2 | Anesthesiology |
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