FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
MIX EVAC II
K Number: K854077
·
Decision Jan 31, 1986
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
12
Applicant Total
124
Review Days
116
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Basic Information
- Device Name
- MIX EVAC II
- K Number
- K854077
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4210
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Stryker Corp.
- Date Received
- October 7, 1985
- Decision Date
- January 31, 1986
- Product Code
- JDZ
- 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 |
|---|---|---|---|
| JDZ | Mixer, Cement, For Clinical Use | FDA class 1 | Orthopedic |
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