SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM


Device Classification Name

staple, implantable

510(k) Number K111153
Device Name SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
Applicant
C.R. BARD, INC.
100 crossings boulevard
warwick, 
RI 
02886

Applicant Contact zheng liu
Correspondent
C.R. BARD, INC.
100 crossings boulevard
warwick, 
RI 
02886

Correspodent Contact zheng liu
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 04/25/2011
Decision Date 05/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No