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 Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K162010
Device Name HPM-6000U
Applicant
BTL Industries, Inc.
47 Loring Dr.
Framingham,  MA  01702
Applicant Contact Jan Zarsky
Correspondent
BTL Industries, Inc.
47 Loring Dr.
Framingham,  MA  01702
Correspondent Contact Jan Zarsky
Regulation Number876.5320
Classification Product Code
KPI  
Date Received07/20/2016
Decision Date 12/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-