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, Nerve, Transcutaneous, For Pain Relief
510(k) Number K921828
Device Name TEAM-MC II
Applicant
HENLEY INTL.
104 INDUSTRIAL BLVD.,
SUGAR LAND,  TX  77470
Applicant Contact ERNEST J HENLELY
Correspondent
HENLEY INTL.
104 INDUSTRIAL BLVD.,
SUGAR LAND,  TX  77470
Correspondent Contact ERNEST J HENLELY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/16/1992
Decision Date 09/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-