Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-