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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K121321
Device Name HARD SHELL VENTED NASAL MASK
Applicant
SLEEPNET CORPORATION
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134 -2958
Applicant Contact PAUL DRYDEN
Correspondent
SLEEPNET CORPORATION
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134 -2958
Correspondent Contact PAUL DRYDEN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/02/2012
Decision Date 11/30/2012
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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