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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory, Mask (Direct Patient Interface)
510(k) Number K070467
Device Name HEALTH MASK
Applicant
POLAR WRAP LLC
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
POLAR WRAP LLC
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5450
Classification Product Code
OBN  
Date Received02/16/2007
Decision Date 04/17/2007
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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