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 Light, Operating, Dental
510(k) Number K891216
Device Name DENTAL EQUIPMENT PROTECTION DEVICES
Applicant
Pro-Safe Professional Linens, Inc.
304 W. Main St.
Grand Junction,  CO  81501
Applicant Contact SCOTT KAFKA
Correspondent
Pro-Safe Professional Linens, Inc.
304 W. Main St.
Grand Junction,  CO  81501
Correspondent Contact SCOTT KAFKA
Regulation Number872.4630
Classification Product Code
EAZ  
Date Received03/07/1989
Decision Date 06/02/1989
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
-
-