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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
Predetermined Change
Control Plan Authorized		 No
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