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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name holding chambers, direct patient interface
510(k) Number K130598
Device Name INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
Applicant
INSPIRX, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
INSPIRX, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
NVP  
Date Received03/07/2013
Decision Date 06/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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