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 Syringe, Piston
510(k) Number K864407
Device Name REFILLABLE SYRINGE
Applicant
Med Fusion Systems, Inc.
3070 Business Park Dr.
Norcross,  GA  30071
Applicant Contact RUFFIN BOOTH
Correspondent
Med Fusion Systems, Inc.
3070 Business Park Dr.
Norcross,  GA  30071
Correspondent Contact RUFFIN BOOTH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/10/1986
Decision Date 01/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-