FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2
K Number: K945238
·
Decision Dec 15, 1994
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
2
Applicant Total
3
Review Days
49
Basic Information
- Device Name
- MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2
- K Number
- K945238
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- F. WALTER HANEL GMBH
- Date Received
- October 27, 1994
- Decision Date
- December 15, 1994
- Product Code
- IWQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IWQ | Curtain, Protective, Radiographic | FDA class 1 | Radiology |
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