SURGICAL OSCILLATING SAW
FDA 510(k) clearance K760958 · decided 1976-11-16
Clearance details
- K-number
- K760958
- Device name
- SURGICAL OSCILLATING SAW
- Applicant
- American Safety Equipment Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-11-01
- Decision date
- 1976-11-16
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DZH
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DENTATUS OSCIOMAT (K031793) | Dentatus USA , Ltd. | 2003-11-13 |
| ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS (K935443) | Osada Electric Co., Ltd. | 1994-09-20 |
| SURGICAL RECIPROCATING SAW (K760957) | American Safety Equipment Corp. | 1976-11-15 |
Recalls involving this device
No recalls on record reference this clearance.