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 K930248
Device Name VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM
Applicant
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Applicant Contact LAURENCE COLIN
Correspondent
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Correspondent Contact LAURENCE COLIN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received01/19/1993
Decision Date 01/07/1994
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
-
-