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510(k) K092580

TIDI FACEMASK by Tidi Products,Llc — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2010
Date Received
August 21, 2009
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 Tidi Products,Llc

  • K132953 — TIDISHEILD (February 18, 2014)
  • K100800 — TIDI FACEMASK (June 14, 2010)

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