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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K042082
Device Name AIRSTRIP OB
Applicant
MP4 SOLUTIONS, LP
11 LYNN BATTS LANE
SAN ANTONIO,  TX  78218
Applicant Contact WILLIAM CAMERON POWELL
Correspondent
MP4 SOLUTIONS, LP
11 LYNN BATTS LANE
SAN ANTONIO,  TX  78218
Correspondent Contact WILLIAM CAMERON POWELL
Regulation Number884.2740
Classification Product Code
HGM  
Date Received08/03/2004
Decision Date 01/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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