510(k) K801148
- Device
- Hemogastat
- Applicant
- THERAPAC, INC.
- 510(k) number
- K801148
- Product code
- JRR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-06-09
- Date received
- 1980-05-13
- Regulation
- 862.2050
- Classification name
- Regulator, Temperature
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- 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#
- 3002889627
- 3043088937
- 3006421415
- 1424489
- 3009420598
- 3015967359
- 3043138885
- 3027645317
- 3035708936
- 3007456622
Source Documents#
510(k) summary PDF not indicated by FDA