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 lubricant, personal
510(k) Number K062796
Device Name K-Y BRAND INTRIGUE
Applicant
PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Applicant Contact NADER FOTOUHI
Correspondent
PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Correspondent Contact NADER FOTOUHI
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/19/2006
Decision Date 12/08/2006
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
-
-