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510(k) K041855

PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S by Aearo Co. — Product Code MSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2004
Date Received
July 9, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

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).

Other clearances by Aearo Co.

  • K072359 — AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C (November 8, 2007)
  • K070168 — N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C (April 18, 2007)
  • K063013 — PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S (December 1, 2006)

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