FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAGITTAL SAW
K Number: K812438
·
Decision Nov 2, 1981
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
40
Applicant Total
11
Review Days
68
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Basic Information
- Device Name
- SAGITTAL SAW
- K Number
- K812438
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Black & Decker(Tm)
- Date Received
- August 26, 1981
- Decision Date
- November 2, 1981
- Product Code
- GEY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Black & Decker(Tm)
| K Number | Device Name | ||
|---|---|---|---|
| K820351 | CAST CUTTER/CAST SAW/INSTRUMENT | Mar 2, 1982 | Substantially Equivalent |
| 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 |
| 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 |