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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K070490
Device Name CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
Applicant
Advanced Circulatory Systems, Inc.
3460 Pointe Creek Ct.
# 102
Bonita Springs,  FL  34134 -2015
Applicant Contact PAUL DRYDEN
Correspondent
Advanced Circulatory Systems, Inc.
3460 Pointe Creek Ct.
# 102
Bonita Springs,  FL  34134 -2015
Correspondent Contact PAUL DRYDEN
Regulation Number868.5690
Classification Product Code
BWF  
Subsequent Product Code
JOW  
Date Received02/20/2007
Decision Date 06/20/2007
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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