FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BEECH PRO LOK FIXED
K Number: K946082
·
Decision Mar 13, 1995
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
4
Review Days
90
Basic Information
- Device Name
- BEECH PRO LOK FIXED
- K Number
- K946082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BEECH MEDICAL PRODUCTS, INC.
- Date Received
- December 13, 1994
- Decision Date
- March 13, 1995
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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