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510(k) K152197

Skypro, SP01 Mask by Skypro Medical Supplies Company — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2016
Date Received
August 5, 2015
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

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