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 Arthroscope
510(k) Number K963524
Device Name KSEA LARGE JOINT ARTHROSCOPY SET
Applicant
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact KEVIN A KENNAN
Correspondent
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact KEVIN A KENNAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/04/1996
Decision Date 11/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-