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 K951619
Device Name UNIVEC NONREUSABLE LOCKING SYRINGE
Applicant
Univec, Inc.
999 Franklin Ave.
Garden City,  NY  11530
Applicant Contact RICHARD SAVADSKY
Correspondent
Univec, Inc.
999 Franklin Ave.
Garden City,  NY  11530
Correspondent Contact RICHARD SAVADSKY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/27/1995
Decision Date 06/06/1995
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
-
-