510(k) K823388
- Device
- TENS MAX
- Applicant
- FUJISAWA ELECTRONICS CO.
- 510(k) number
- K823388
- Product code
- GFK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-08
- Date received
- 1982-11-15
- Regulation
- 864.7340
- Classification name
- Fibrinogen Determination Standards And Controls
- 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#
- 9610806
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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