510(k) K801914
- Device
- Temp Sternum Saw
- Applicant
- TEMP MEDICAL PRODUCTS, INC.
- 510(k) number
- K801914
- Product code
- DWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-23
- Date received
- 1980-08-11
- Regulation
- 878.4820
- Classification name
- Saw, Electrically Powered
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1422375
- 3003800209
- 3012494290
- 1836161
- 8010697
- 9610612
- 3015972835
- 8040278
- 3043148563
- 1055890
- 8010704
- 9611253
- 3043088060
- 8043496
- 9611112
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DWI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K912237 | STRYKER ECLIPSE WARMING STRETCHER | Stryker Medical | 1991-07-30 |