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 Introducer, Syringe Needle
510(k) Number K883164
Device Name INSTAJECT II
Applicant
Pavel Jordan & Associates, Inc.
3001 Chapel Hill Rd.
Orange,  CA  92667
Applicant Contact KRAWITZ
Correspondent
Pavel Jordan & Associates, Inc.
3001 Chapel Hill Rd.
Orange,  CA  92667
Correspondent Contact KRAWITZ
Regulation Number880.6920
Classification Product Code
KZH  
Date Received07/27/1988
Decision Date 10/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-