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 Mouthpiece, Saliva Ejector
510(k) Number K921117
Device Name MINIDAM
Applicant
Delsan Dental Systems
108 Howard Way
Pennington,  NJ  08534
Applicant Contact DE LUCA
Correspondent
Delsan Dental Systems
108 Howard Way
Pennington,  NJ  08534
Correspondent Contact DE LUCA
Regulation Number872.6640
Classification Product Code
DYN  
Date Received03/09/1992
Decision Date 05/05/1992
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
-
-