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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K132870
Device Name Origio Gas Line Filter
Applicant
Origio, Inc.
2400 Hunters Way
Charlottesville,  VA  22911
Applicant Contact JOHN CLAY
Correspondent
Origio, Inc.
2400 Hunters Way
Charlottesville,  VA  22911
Correspondent Contact JOHN CLAY
Regulation Number884.6120
Classification Product Code
MQG  
Date Received09/13/2013
Decision Date 05/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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