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 Material, Impression
510(k) Number K030318
Device Name P2 POLYETHER
Applicant
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND,  IN  46614 -2517
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND,  IN  46614 -2517
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received01/30/2003
Decision Date 04/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-