FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CEMENT FUME EVACUATOR TANK & FILTER
K Number: K810542
·
Decision Mar 13, 1981
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
7
Applicant Total
3
Review Days
14
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Basic Information
- Device Name
- CEMENT FUME EVACUATOR TANK & FILTER
- K Number
- K810542
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4220
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Walgen Medical Innoventions
- Date Received
- February 27, 1981
- Decision Date
- March 13, 1981
- Product Code
- JDY
- 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 |
|---|---|---|---|
| JDY | Evacuator, Vapor, Cement Monomer | FDA class 1 | Orthopedic |
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