510(k) K800699
- Device
- Flo Tem (fluid Warner)
- Applicant
- CHROMA PRODUCTS, INC.
- 510(k) number
- K800699
- Product code
- KZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-08
- Date received
- 1980-03-28
- Regulation
- 864.9205
- Classification name
- Device, Warming. Blood And Plasma
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9681384
- 3005941719
- 1722028
- 3012307300
- 3006946102
- 2133810
- 9616567
- 3031841433
- 3042272797
- 9617475
- 9617604
- 1643817
- 2032112
- 3016543974
- 1649518
Source Documents#
510(k) summary PDF not indicated by FDA