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, Antistick
510(k) Number K000572
Device Name E.N.S.I. SYRINGE
Applicant
Tri-Ject Intl. Corp.
310 Meridian N., Suite 6
Puyallup,  WA  98371
Applicant Contact PETER G LEMIN
Correspondent
Tri-Ject Intl. Corp.
310 Meridian N., Suite 6
Puyallup,  WA  98371
Correspondent Contact PETER G LEMIN
Regulation Number880.5860
Classification Product Code
MEG  
Date Received02/22/2000
Decision Date 02/24/2000
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
-
-