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 K040671
Device Name EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
Applicant
Anthogyr
164 Rue De Trois Lacs
Sallanches,  FR 74700
Applicant Contact ERIC GENEVE
Correspondent
Anthogyr
164 Rue De Trois Lacs
Sallanches,  FR 74700
Correspondent Contact ERIC GENEVE
Regulation Number872.6770
Classification Product Code
EJI  
Date Received03/15/2004
Decision Date 12/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-