FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAST CUTTER/CAST SAW/INSTRUMENT
K Number: K820351
·
Decision Mar 2, 1982
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
11
Review Days
22
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Basic Information
- Device Name
- CAST CUTTER/CAST SAW/INSTRUMENT
- K Number
- K820351
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5960
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Black & Decker(Tm)
- Date Received
- February 8, 1982
- Decision Date
- March 2, 1982
- 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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Other Clearances by Black & Decker(Tm)
| K Number | Device Name | ||
|---|---|---|---|
| K812437 | 150 DRIVER REAMER | Nov 2, 1981 | Substantially Equivalent |
| K812439 | DUAL MPC CHARGER | Nov 2, 1981 | Substantially Equivalent |
| K812440 | POWER PACK | Nov 2, 1981 | Substantially Equivalent |
| K812436 | 450/800 DRILL | Nov 2, 1981 | Substantially Equivalent |
| K812438 | SAGITTAL SAW | Nov 2, 1981 | Substantially Equivalent |
| K800315 | DUAL MPC CHARGER | Mar 19, 1980 | Substantially Equivalent |
| K800314 | POWER PACK | Mar 19, 1980 | Substantially Equivalent |
| K800311 | 450 DRILL/800 DRILL | Feb 22, 1980 | Substantially Equivalent |
| K800312 | 150 DRIVER/REAMER | Feb 22, 1980 | Substantially Equivalent |
| K800313 | SAGITTAL SAW | Feb 22, 1980 | Substantially Equivalent |