FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
450 DRILL/800 DRILL
K Number: K800311
·
Decision Feb 22, 1980
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
11
Review Days
10
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Basic Information
- Device Name
- 450 DRILL/800 DRILL
- K Number
- K800311
- 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
- February 12, 1980
- Decision Date
- February 22, 1980
- Product Code
- KIJ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | 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 |
| 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 |
| K800312 | 150 DRIVER/REAMER | Feb 22, 1980 | Substantially Equivalent |
| K800313 | SAGITTAL SAW | Feb 22, 1980 | Substantially Equivalent |