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 K162207
FOIA Releasable 510(k) K162207
Device Name Restore Moisturizing Vaginal Lubricant
Applicant
Good Clean Love
207 W 5th Ave.
Eugene,  OR  97401
Applicant Contact Wendy Strgar
Correspondent
S. Hesler Compliance Engineering
2602 5th Ave.
West Linn,  OR  97068
Correspondent Contact Steve Hesler
Regulation Number884.5300
Classification Product Code
NUC  
Date Received08/05/2016
Decision Date 05/04/2017
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
-
-