FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL OSCILLATING SAW
K Number: K760958
·
Decision Nov 16, 1976
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
7
Review Days
15
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Basic Information
- Device Name
- SURGICAL OSCILLATING SAW
- K Number
- K760958
- 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 16, 1976
- Product Code
- DZH
- 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 |
|---|---|---|---|
| DZH | Saw, Bone, Ac-Powered | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZH), ordered by most recent decision date.
DENTATUS OSCIOMAT
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ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
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SURGICAL RECIPROCATING SAW
FDA 510(k)
FDA Class 2
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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 |
| K760960 | SURGICAL WIRE DRIVER | Nov 19, 1976 | Substantially Equivalent |
| K760957 | SURGICAL RECIPROCATING SAW | Nov 15, 1976 | Substantially Equivalent |
| K760959 | SURGICAL CHISEL | Nov 15, 1976 | Substantially Equivalent |