FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL RECIPROCATING SAW
K Number: K760957
·
Decision Nov 15, 1976
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
7
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SURGICAL RECIPROCATING SAW
- K Number
- K760957
- 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 15, 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
FDA 510(k)
FDA Class 2
·Dental
ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
FDA 510(k)
FDA Class 2
·Dental
SURGICAL OSCILLATING SAW
FDA 510(k)
FDA Class 2
·Dental
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 |
| K760958 | SURGICAL OSCILLATING SAW | Nov 16, 1976 | Substantially Equivalent |
| K760959 | SURGICAL CHISEL | Nov 15, 1976 | Substantially Equivalent |