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
510(k) Number K870524
Device Name AMBULATORY INFUSION PUMP DRUG RESERVOIR
Applicant
MEDFUSION SYSTEMS, INC.
3070 BUSINESS PARK DR.
NORCROSS,  GA  30071
Applicant Contact RUFFIN BOOTH
Correspondent
MEDFUSION SYSTEMS, INC.
3070 BUSINESS PARK DR.
NORCROSS,  GA  30071
Correspondent Contact RUFFIN BOOTH
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/06/1987
Decision Date 05/06/1987
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
-
-