KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1


Device Classification Name

insufflator, laparoscopic

510(k) Number K080852
Device Name KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Applicant Contact crystal dizol
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Correspodent Contact crystal dizol
Regulation Number 884.1730
Classification Product Code
HIF  
Date Received 03/26/2008
Decision Date 03/30/2009
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