FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL WIRE DRIVER
K Number: K760960
·
Decision Nov 19, 1976
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
31
Applicant Total
7
Review Days
18
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Basic Information
- Device Name
- SURGICAL WIRE DRIVER
- K Number
- K760960
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- American Safety Equipment Corp.
- Date Received
- November 1, 1976
- Decision Date
- November 19, 1976
- Product Code
- DZJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZJ | Driver, Wire, And Bone Drill, Manual | FDA class 2 | Dental |
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Other Clearances by American Safety Equipment Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K801010 | KIRSCHNER WIRE | May 20, 1980 | Substantially Equivalent |
| K771699 | CARA-STAIN MODEL 3000 | Sep 13, 1977 | Substantially Equivalent |
| K760956 | SURGICAL MICRO DRILL | Nov 19, 1976 | Substantially Equivalent |
| K760958 | SURGICAL OSCILLATING SAW | Nov 16, 1976 | Substantially Equivalent |
| K760957 | SURGICAL RECIPROCATING SAW | Nov 15, 1976 | Substantially Equivalent |
| K760959 | SURGICAL CHISEL | Nov 15, 1976 | Substantially Equivalent |