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510(k) K962443

N95 FILTERING FACEPIECE by Survivair, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1997
Date Received
June 24, 1996
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 Survivair, Inc.

  • K070139 — WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 (March 2, 2007)

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