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 Polymer Patient Examination Glove
510(k) Number K113440
Device Name HIGH FIVE
Applicant
Central Medicare Sdn Bhd
1930 Brea Canyon Rd.
Diamond Bar
Diamond Bar,  CA  91765
Applicant Contact NICK WANG
Correspondent
Central Medicare Sdn Bhd
1930 Brea Canyon Rd.
Diamond Bar
Diamond Bar,  CA  91765
Correspondent Contact NICK WANG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/21/2011
Decision Date 05/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-