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 Condom
510(k) Number K161195
Device Name Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
Applicant
M3 Global Enterprises, LLC
70 Birch Alley, Suite 240 Bldg. B
Beavercreek,  OH  45440
Applicant Contact NEIL MEHTA
Correspondent
Registrar Corp.
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact Lara Luzak
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/27/2016
Decision Date 08/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-