RHEA CUP


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

Correspodent Contact scott herrick
Regulation Number 884.5400
Classification Product Code
HHE  
Date Received 07/28/2011
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