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510(k) K032438

Device
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
Applicant
TYCO HEALTHCARE
510(k) number
K032438
Product code
NGT  
Decision
Substantially Equivalent (SESE)
Decision date
2004-06-30
Date received
2003-08-07
Regulation
880.5200
Classification name
Saline, Vascular Access Flush
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID OLSON
Address
15 Hampshire St. Mansfield MA US 02048 02048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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