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510(k) K110455

KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS by Kimberly-Clark Corp. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2011
Date Received
February 15, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAP (January 19, 2012)

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