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510(k) K141875

Pasture 60S Surgical Mask by Pasture Pharma Pte, Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2015
Date Received
July 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Pasture Pharma Pte, Ltd.

  • K141876 — Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, P (October 28, 2015)
  • K083176 — PASTURE, MODELS: F550, A520 (January 23, 2009)

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