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 Needle, Dental
510(k) Number K910475
Device Name DENTAL NEEDLE PROTECTIVE SYSTEM
Applicant
Health Technology Systems, Inc.
114 Woodland Ave.
Lexington,  KY  40502
Applicant Contact HENRY EVANS
Correspondent
Health Technology Systems, Inc.
114 Woodland Ave.
Lexington,  KY  40502
Correspondent Contact HENRY EVANS
Regulation Number872.4730
Classification Product Code
DZM  
Date Received02/06/1991
Decision Date 09/13/1991
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
-
-