510(k) K894657
- Device
- POLYSTAN HEART-LUNG MACHINE SYSTEM
- Applicant
- POLYSTAN C/O VITALCOR, INC.
- 510(k) number
- K894657
- Product code
- DJQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-28
- Date received
- 1989-07-24
- Regulation
- 862.3670
- Classification name
- Test Reagents For Phenothiazine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HENNING LARSEN
- Address
- 8, Walgerholm Dk-3500 Vaerlose Denmark DK
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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