NEW MESH PRODUCT CLEARED THROUGH FDA 510k PROCESS!

Speak up!

Speak up!

MORE HERE: http://tinyurl.com/ozm6fd4 

CONTACT THE FDA AND 
HOLD THEM RESPONSIBLE!
Here is the link to the FDA's Summary of approval, citing "substantial equivalence."
http://www.accessdata.fda.gov/cdrh_docs/pdf14/K141560.pdf


FDA MEDWATCH:
https://www.accessdata.fda.gov/scripts/medwatch/
Report ANY and ALL Adverse Events (negative side effects/symptoms) to the FDA.

Report ANY and ALL Adverse Events (negative side effects/symptoms) to the FDA.









DEVICE: 
Parietex Monofilament Polyester Mesh 
(new name: Parietex Lightweight Mesh)
Parietex Composite Mono PM Mesh 
(new name: Parietex Composite Parastomal Mesh)
Parietex Composite Ventral Patch
Symbotex Composite Mesh

SOFRADIM PRODUCTION             
ATTN: Eric  Jague               
116 AVENUE DU FORMANS           
TREVOUX  FR 01600
510(k) NO: K142908(Special)
PHONE NO : 33 474 089000 
SE DECISION MADE: 14-NOV-14
510(k) SUMMARY AVAILABLE FROM FDA

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