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 Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K990996
Device Name GENYX MEDICAL INJECTION NEEDLE
Applicant
Genyx Medical, Inc.
36 Argonaut, Suite 100
Aliso Viejo,  CA  92656 -1467
Applicant Contact JUDY F GORDON
Correspondent
Genyx Medical, Inc.
36 Argonaut, Suite 100
Aliso Viejo,  CA  92656 -1467
Correspondent Contact JUDY F GORDON
Regulation Number876.1500
Classification Product Code
FBK  
Date Received03/25/1999
Decision Date 06/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-