ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR


Device Classification Name

washer, bolt nut

510(k) Number K112111
Device Name ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
Applicant
ACUMED LLC
5885 nw cornelius pass rd.
hillsboro, 
OR 
97124 -9432

Applicant Contact lino tsai
Correspondent
ACUMED LLC
5885 nw cornelius pass rd.
hillsboro, 
OR 
97124 -9432

Correspodent Contact lino tsai
Regulation Number 888.3030
Classification Product Code
HTN  
Subsequent Product Codes
HRS   HWC   MBI  
Date Received 07/25/2011
Decision Date 11/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No