• 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 stent, vaginal
510(k) Number K202542
Device Name Allura Vaginal Stent
Applicant
PMT Corporation
1500 Park Road
chanhassen,  MN  55317
Applicant Contact matt cree
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact prithul bom
Regulation Number884.3900
Classification Product Code
KXP  
Date Received09/02/2020
Decision Date 09/30/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
statement statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-