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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 K100343
Device Name PAP-CAP
Applicant
PUR-SLEEP, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
PUR-SLEEP, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/05/2010
Decision Date 04/23/2010
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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