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 Handpiece, Direct Drive, Ac-Powered
510(k) Number K915634
Device Name FRESENIUS PD+ EXCHANGE DEVICE
Applicant
Fresenius USA, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact TOM FOLDEN
Correspondent
Fresenius USA, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact TOM FOLDEN
Regulation Number872.4200
Classification Product Code
EKX  
Date Received12/17/1991
Decision Date 07/01/1993
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
-
-