FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QCR SYSTEM I AND QCR SYSTEM II
K Number: K893380
·
Decision Nov 16, 1989
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
1
Review Days
199
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Basic Information
- Device Name
- QCR SYSTEM I AND QCR SYSTEM II
- K Number
- K893380
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5960
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Bremer Mfg. & Tool Co., Inc.
- Date Received
- May 1, 1989
- Decision Date
- November 16, 1989
- Product Code
- LGH
- 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 |
|---|---|---|---|
| LGH | Instrument, Cast Removal, Ac-Powered | FDA class 1 | Orthopedic |
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