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 Crown, Preformed
510(k) Number K883325
Device Name PERFORMED CROWN (STAINLESS STEEL)
Applicant
Whitecap Dental Co.
Box Ab
Swarthmore,  PA  19081
Applicant Contact LESTER E BURGESS
Correspondent
Whitecap Dental Co.
Box Ab
Swarthmore,  PA  19081
Correspondent Contact LESTER E BURGESS
Regulation Number872.3330
Classification Product Code
ELZ  
Date Received08/05/1988
Decision Date 09/16/1988
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
-
-