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 K970594
Device Name KALGINATE IMPRESSION MATERIAL
Applicant
Teledyne Water Pik
1730 E. Prospect Rd.
Fort Collins,  CO  80525
Applicant Contact MICHAEL J RYAN
Correspondent
Teledyne Water Pik
1730 E. Prospect Rd.
Fort Collins,  CO  80525
Correspondent Contact MICHAEL J RYAN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received02/18/1997
Decision Date 03/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-