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 Syringe, Cartridge
510(k) Number K922683
Device Name PRESTYL JET INJECTOR
Applicant
Bma Technologies S.A.
1140 Nineteenth Steet, NW
Washington,  DC  20036
Applicant Contact RICHARD S MOREY
Correspondent
Bma Technologies S.A.
1140 Nineteenth Steet, NW
Washington,  DC  20036
Correspondent Contact RICHARD S MOREY
Regulation Number872.6770
Classification Product Code
EJI  
Date Received06/04/1992
Decision Date 04/11/1994
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
-
-