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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K093218
Device Name FEMEYE TWO
Applicant
FEMSUITE, LLC
19991 7TH STREET EAST
SONOMA,  CA  95476
Applicant Contact PAVAN SETHI
Correspondent
FEMSUITE, LLC
19991 7TH STREET EAST
SONOMA,  CA  95476
Correspondent Contact PAVAN SETHI
Regulation Number884.1690
Classification Product Code
HIH  
Date Received10/13/2009
Decision Date 05/18/2010
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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