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, retention type, balloon
510(k) Number K031748
Device Name VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
Applicant
VITALCARE GROUP, INC.
8935 N.W. 27TH ST.
MIAMI,  FL  33172
Applicant Contact MICHAEL MCAVENIA
Correspondent
VITALCARE GROUP, INC.
8935 N.W. 27TH ST.
MIAMI,  FL  33172
Correspondent Contact MICHAEL MCAVENIA
Regulation Number876.5130
Classification Product Code
EZL  
Date Received06/05/2003
Decision Date 08/27/2003
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
-
-