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 table, operating-room, ac-powered
510(k) Number K936308
Device Name ENDEX ENDOSCOPIC POSITIONING SYSTEM
Applicant
ANDRONIC DEVICES, LTD.
SUITE 140
13120 VANIER PLACE
RICHMOND, B.C. CANADA V6V 2J2,  CA V6V 2J2
Applicant Contact ROBERT MACNEIL
Correspondent
ANDRONIC DEVICES, LTD.
SUITE 140
13120 VANIER PLACE
RICHMOND, B.C. CANADA V6V 2J2,  CA V6V 2J2
Correspondent Contact ROBERT MACNEIL
Regulation Number878.4960
Classification Product Code
FQO  
Date Received12/20/1993
Decision Date 03/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-