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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 K072755
Device Name GALEMED CPAP MASK
Applicant
Galemed Corp.
3460 Pointe Creek Court
Suite 102
Bonita Springs,  FL  34134 -2015
Applicant Contact PAUL DRYDEN
Correspondent
Galemed Corp.
3460 Pointe Creek Court
Suite 102
Bonita Springs,  FL  34134 -2015
Correspondent Contact PAUL DRYDEN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/27/2007
Decision Date 11/16/2007
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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