• 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 Insufflator, Laparoscopic
510(k) Number K963423
Device Name KSEA CO2 ENDOFLATOR
Applicant
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact KEVIN A KENNAN
Correspondent
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact KEVIN A KENNAN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/30/1996
Decision Date 05/27/1997
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
-
-