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 Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K931181
Device Name VESITEC SUTURE PASSER
Applicant
Vesitec Medical, Inc.
26072 Merit Cir.
Suite 125
Laguna Hills,  CA  92653
Applicant Contact LINDA D'ABATE
Correspondent
Vesitec Medical, Inc.
26072 Merit Cir.
Suite 125
Laguna Hills,  CA  92653
Correspondent Contact LINDA D'ABATE
Regulation Number876.4730
Classification Product Code
KOA  
Date Received03/09/1993
Decision Date 05/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-