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510(k) K133070

SURGICAL FACE MASK (Ear Loops and Tie-on) by Bh Medical Products Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2015
Date Received
September 30, 2013
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 Bh Medical Products Co., Ltd.

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