FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TEMP STERNUM SAW
K Number: K801914
·
Decision Oct 23, 1980
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
1
Applicant Total
2
Review Days
73
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
- TEMP STERNUM SAW
- K Number
- K801914
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Temp Medical Products, Inc.
- Date Received
- August 11, 1980
- Decision Date
- October 23, 1980
- Product Code
- DWI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| DWI | Saw, Electrically Powered | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWI), ordered by most recent decision date.
View allOther Clearances by Temp Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830189 | CARDIOVASCULAR SAW BLADES | Mar 24, 1983 | Substantially Equivalent |