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 Controller, Infusion, Intravascular, Electronic
510(k) Number K935236
Device Name FLOW CONTROLLING EXTENSION SET
Applicant
Block Medical, Inc.
5957 Landau Ct.
Carlsbad,  CA  92008
Applicant Contact GEORGE T WALKER
Correspondent
Block Medical, Inc.
5957 Landau Ct.
Carlsbad,  CA  92008
Correspondent Contact GEORGE T WALKER
Regulation Number880.5725
Classification Product Code
LDR  
Date Received11/01/1993
Decision Date 02/24/1994
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
-
-