FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
K Number: K132883
·
Decision Nov 1, 2013
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
4
Review Days
49
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Basic Information
- Device Name
- HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
- K Number
- K132883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hemodia Sas
- Date Received
- September 13, 2013
- Decision Date
- November 1, 2013
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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