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510(k) K132679

AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER by Galemed Corp. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2014
Date Received
August 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Galemed Corp.

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  • K072755 — GALEMED CPAP MASK (November 16, 2007)
  • K022124 — GALEMED PEAK FLOW METER, MODELS 3751/3752 (April 3, 2003)
  • K021742 — GALEMED NEB-EASY NEBULIZER (October 25, 2002)

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