510(k) K872086
- Device
- ACUSYST-JR
- Applicant
- ENDOTRONICS, INC.
- 510(k) number
- K872086
- Product code
- KJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-15
- Date received
- 1987-06-01
- Regulation
- 864.2240
- Classification name
- Apparatus, Perfusion
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- BERNARD E HORWATH
- Address
- 8500 Evergreen Blvd. Coon Rapids MN US 55433 55433
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KJH
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases