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 laparoscope, gynecologic (and accessories)
510(k) Number K965121
Device Name CANNULA
Applicant
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Applicant Contact ANTHONY DURSO
Correspondent
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Correspondent Contact ANTHONY DURSO
Regulation Number884.1720
Classification Product Code
HET  
Date Received12/23/1996
Decision Date 03/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-