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510(k) K021742

GALEMED NEB-EASY NEBULIZER by Galemed Corp. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2002
Date Received
May 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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  • K082092 — DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXE (October 15, 2008)
  • K072755 — GALEMED CPAP MASK (November 16, 2007)
  • K022124 — GALEMED PEAK FLOW METER, MODELS 3751/3752 (April 3, 2003)

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