510(k) K791164
- Device
- NEGATOVE PRESSURE CONVERTOR
- Applicant
- MEDICORP, INC.
- 510(k) number
- K791164
- Product code
- FLC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-10-04
- Date received
- 1979-06-25
- Regulation
- 876.5820
- Classification name
- Station, Dialysis Control, Negative Pressure Type
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FLC #
Legacy Summary#
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FDA Review#
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