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 Pump, Infusion, Elastomeric
510(k) Number K072921
Device Name DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
Applicant
SYMBIOS MEDICAL PRODUCTS, LLC
7301 GEORGETOWN RD
SUITE 150
INDIANAPOLIS,  IN  46268 -4194
Applicant Contact JEFFREY ALHOLM
Correspondent
SYMBIOS MEDICAL PRODUCTS, LLC
7301 GEORGETOWN RD
SUITE 150
INDIANAPOLIS,  IN  46268 -4194
Correspondent Contact JEFFREY ALHOLM
Regulation Number880.5725
Classification Product Code
MEB  
Subsequent Product Codes
BSO   KGZ  
Date Received10/15/2007
Decision Date 11/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-