FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL MICRO DRILL
K Number: K760956
·
Decision Nov 19, 1976
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
12
Applicant Total
7
Review Days
18
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Basic Information
- Device Name
- SURGICAL MICRO DRILL
- K Number
- K760956
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4130
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- American Safety Equipment Corp.
- Date Received
- November 1, 1976
- Decision Date
- November 19, 1976
- Product Code
- DZA
- 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 |
|---|---|---|---|
| DZA | Drill, Dental, Intraoral | FDA class 1 | 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 |
| K760960 | SURGICAL WIRE DRIVER | 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 |