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510(k) K080827

HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 by Handan Hengyong Protective & Clean Products Co., L — Product Code MSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2008
Date Received
March 25, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).  Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures subject to 21 CFR 878.9 and the conditions for exemption identified in 21 CFR 878.4040(b)(1).

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