SILMAX CONTOUR CARVING BLOCK IMPLANT


definition

Device Classification Name

polymer, ent synthetic, porous polyethylene

510(k) Number K002629
Device Name SILMAX CONTOUR CARVING BLOCK IMPLANT
Original Applicant
PILLAR SURGICAL, INC.
p.o. box 8141
la jolla, 
CA 
92038

Original Contact rob fritzenkotter
Regulation Number 874.3620
Classification Product Code
JOF  
Date Received 08/23/2000
Decision Date 11/20/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No