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 K213547
Device Name SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
Applicant
TTK Healthcare Limited
12, K P Natham Road, Thiruvandar Koil,
Puducherry,  IN 605102
Applicant Contact Daniel J S
Correspondent
TTK Healthcare Limited
6, Cathedral Road
Chennai,  IN 600086
Correspondent Contact Daniel J S
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/08/2021
Decision Date 12/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-