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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spacer, direct patient interface
510(k) Number K101532
Device Name NESSI OTC SPACER
Applicant
PHARMACARIBE
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
PHARMACARIBE
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
NVO  
Date Received06/03/2010
Decision Date 09/01/2010
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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