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 Burnisher, Operative
510(k) Number K880590
Device Name DISPOSABLE DENTAL PROBE/EXPLORER
Applicant
Baxter Healthcare Corp
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Applicant Contact BETSY A BROWN
Correspondent
Baxter Healthcare Corp
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Correspondent Contact BETSY A BROWN
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received02/11/1988
Decision Date 03/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-