ENDOTACK


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K022853
Device Name ENDOTACK
Original Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Original Contact james a lee
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 08/27/2002
Decision Date 11/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No