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 Set, Administration, Intravascular
510(k) Number K120685
Device Name ZYNO MEDICAL ADMINISTRATION SET
Applicant
ZYNO MEDICAL LLC
10 TECH CIRCLE
NATICK,  MA  01760
Applicant Contact CHAOYOUNG LEE
Correspondent
ZYNO MEDICAL LLC
10 TECH CIRCLE
NATICK,  MA  01760
Correspondent Contact CHAOYOUNG LEE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/06/2012
Decision Date 09/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-