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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 K120107
Models 1, 2
Device Name SCKOONCUP
Applicant
SCKOON INC.
2301 collins ave
#310
miami beach,  FL  33139
Contact mohamed elgayar
Regulation Number884.5400
Classification Product Code
HHE  
Date Received01/13/2012
Decision Date 09/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-