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 Indicator, Biological Sterilization Process
510(k) Number K004009
Device Name 3M ATTEST 290 AUTO-READER
Applicant
3M Company
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Applicant Contact STEPHAN NORSTED
Correspondent
3M Company
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact STEPHAN NORSTED
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/26/2000
Decision Date 03/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-