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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cup, menstrual
510(k) Number K112165
Device Name RHEA CUP
Applicant
APEX MEDICAL TECHNOLOGIES, INC.
10064 MESA RIDGE CT., #202
SAN DIEGO,  CA  92121
Applicant Contact SCOTT HERRICK
Correspondent
APEX MEDICAL TECHNOLOGIES, INC.
10064 MESA RIDGE CT., #202
SAN DIEGO,  CA  92121
Correspondent Contact SCOTT HERRICK
Regulation Number884.5400
Classification Product Code
HHE  
Date Received07/28/2011
Decision Date 05/24/2012
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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