FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRESSURIZING/SCAVENGING ACRYLIC CEMENT
K Number: K840046
·
Decision Feb 9, 1984
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
10
Applicant Total
3
Review Days
34
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Basic Information
- Device Name
- PRESSURIZING/SCAVENGING ACRYLIC CEMENT
- K Number
- K840046
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4200
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Precision Medical Devices, Inc.
- Date Received
- January 6, 1984
- Decision Date
- February 9, 1984
- Product Code
- KIH
- 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 |
|---|---|---|---|
| KIH | Dispenser, Cement | FDA class 1 | Orthopedic |
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