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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name labware, assisted reproduction
510(k) Number K112644
Device Name SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
Applicant
LOTUS BIO LTD
461 MAIN STREET
SUITE 217
PAWTUCKET,  RI  02860
Applicant Contact LORI KAHLER
Correspondent
LOTUS BIO LTD
461 MAIN STREET
SUITE 217
PAWTUCKET,  RI  02860
Correspondent Contact LORI KAHLER
Regulation Number884.6160
Classification Product Code
MQK  
Subsequent Product Code
MQG  
Date Received09/12/2011
Decision Date 12/19/2012
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
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