510(k) K852140
- Device
- NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)
- Applicant
- NORTH AMERICAN INSTRUMENT CORP.
- 510(k) number
- K852140
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-30
- Date received
- 1985-05-16
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- PHILLIP H MORSE
- Address
- NY US 12839 12839
FDA Registration Numbers
- 1450662
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
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Legacy Summary
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FDA Review
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