FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMA SHAVER BLADES
K Number: K060172
·
Decision May 31, 2006
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
669
Applicant Total
1
Review Days
128
Basic Information
- Device Name
- REMA SHAVER BLADES
- K Number
- K060172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- REMA MEDIZINTECHNIK GMBH.
- Date Received
- January 23, 2006
- Decision Date
- May 31, 2006
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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