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510(k) K083176

PASTURE, MODELS: F550, A520 by Pasture Pharma Pte, Ltd. — Product Code NZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2009
Date Received
October 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Device Class
Class II
Regulation Number
880.6260
Review Panel
HO
Submission Type

It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.

Other clearances by Pasture Pharma Pte, Ltd.

  • K141876 — Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, P (October 28, 2015)
  • K141875 — Pasture 60S Surgical Mask (May 5, 2015)

Other clearances for product code NZJ

  • DEN060009 — 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR (May 8, 2007)