ENDOBUTTON CONTINUOUS LOOP (CL)


Device Classification Name

staple, fixation, bone

510(k) Number K081098
Device Name ENDOBUTTON CONTINUOUS LOOP (CL)
Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
150 minuteman rd.
andover, 
MA 
01810

Applicant Contact christina flores
Correspondent
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
150 minuteman rd.
andover, 
MA 
01810

Correspodent Contact christina flores
Regulation Number 888.3030
Classification Product Code
JDR  
Subsequent Product Codes
HWC   MBI  
Date Received 04/17/2008
Decision Date 07/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No