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 Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K932789
Device Name ONE-SITE IV CONNECTOR
Applicant
Care Medical Devices, Inc.
1440 S. Carlos Ave.
Ontario,  CA  91761
Applicant Contact ROBERT J BARD
Correspondent
Care Medical Devices, Inc.
1440 S. Carlos Ave.
Ontario,  CA  91761
Correspondent Contact ROBERT J BARD
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/09/1993
Decision Date 07/28/1994
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
-
-