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510(k) K171162

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield by Prestige Ameritech — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2017
Date Received
April 20, 2017
Clearance Type
Abbreviated
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

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  • K061716 — PRESTIGE AMERITECH FACE MASK (August 14, 2006)

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  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
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