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 Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K220364
Device Name Accu-Chek Safe-T-Pro Uno Lancing Device
Applicant
Roche Diabetes Care, Inc.
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact Julia Best
Correspondent
Roche Diabetes Care, Inc.
9115 Hague Road
Indianapolis,  IL  46055
Correspondent Contact Julia Best
Regulation Number878.4850
Classification Product Code
FMK  
Date Received02/08/2022
Decision Date 04/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-