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 K251011
Device Name Chiavaye Personal Moisturizer
Applicant
Unipack, LLC
111 Coolidge St.
South Plainfield,  NJ  07080
Applicant Contact Dinesh Patel
Correspondent
Unipack, LLC
111 Coolidge St.
South Plainfield,  NJ  07080
Correspondent Contact Dinesh Patel
Regulation Number884.5300
Classification Product Code
NUC  
Date Received04/01/2025
Decision Date 12/19/2025
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
-
-