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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nebulizer (direct patient interface)
510(k) Number K090840
Device Name VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
Applicant
VENTLAB CORP.
155 BOYCE DRIVE
MOCKSVILLE,  NC  27028
Applicant Contact JAMES A COCHIE
Correspondent
VENTLAB CORP.
155 BOYCE DRIVE
MOCKSVILLE,  NC  27028
Correspondent Contact JAMES A COCHIE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/27/2009
Decision Date 06/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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