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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 K140062
Device Name FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
Applicant
FSC LABORATORIES, INC.
6000 Fairview Rd.
Suite 600
Charlotte,  NC  28210
Applicant Contact PAUL DRYDEN
Correspondent
FSC LABORATORIES, INC.
6000 Fairview Rd.
Suite 600
Charlotte,  NC  28210
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
NVP  
Date Received01/10/2014
Decision Date 10/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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