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 tubing, noninvasive
510(k) Number K930512
Device Name SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES
Applicant
CORE DYNAMICS, INC.
11222-4 ST. JOHNS
INDUSTRIAL PARKWAY
JACKSONVILLE,  FL  32246
Applicant Contact TIM REIS
Correspondent
CORE DYNAMICS, INC.
11222-4 ST. JOHNS
INDUSTRIAL PARKWAY
JACKSONVILLE,  FL  32246
Correspondent Contact TIM REIS
Regulation Number880.6740
Classification Product Code
GAZ  
Date Received02/01/1993
Decision Date 07/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-