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510(k) K061716

PRESTIGE AMERITECH FACE MASK by Prestige Ameritech — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2006
Date Received
June 19, 2006
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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