JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS


Device Classification Name

coagulator-cutter, endoscopic, unipolar (and accessories)

510(k) Number K103726
Device Name JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
Applicant
INTEGRA LIFESCIENCES CORPORATION
589 davies drive
york, 
PA 
17402

Applicant Contact stephanie sheesley
Correspondent
INTEGRA LIFESCIENCES CORPORATION
589 davies drive
york, 
PA 
17402

Correspodent Contact stephanie sheesley
Regulation Number 884.4160
Classification Product Code
KNF  
Date Received 12/22/2010
Decision Date 02/08/2012
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

Recalls CDRH Recalls