510(k) K854084
- Device
- PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT
- Applicant
- ORGANON TEKNIKA CORP.
- 510(k) number
- K854084
- Product code
- FKL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-08
- Date received
- 1985-10-07
- Regulation
- 876.5820
- Classification name
- Insert, Pump, Blood
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN ROBERTS
- Address
- 5300 S. Portland Ave. Oklahoma City OK US 73119 73119
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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