510(k) K772163
- Device
- DIALYSIS MACHINES DM-346 & 346-1
- Applicant
- EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
- 510(k) number
- K772163
- Product code
- FIJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-11-28
- Date received
- 1977-11-16
- Regulation
- 876.5820
- Classification name
- System, Dialysate Delivery, Recirculating, Single Pass
- 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
Legacy Summary#
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FDA Review#
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