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510(k) K083176

Device
PASTURE, MODELS: F550, A520
Applicant
PASTURE PHARMA PTE LTD
510(k) number
K083176
Product code
NZJ  
Decision
Substantially Equivalent (SESE)
Decision date
2009-01-23
Date received
2008-10-28
Regulation
880.6260
Classification name
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
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
SARAH HASSAN
Address
29266 Via Frontera Murrieta CA US 92563 92563

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NZJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
DEN0600093M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR3M Company2007-05-08

Legacy Summary#

summary

FDA Review#

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