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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ent Synthetic, Porous Polyethylene
510(k) Number K002629
Device Name SILMAX CONTOUR CARVING BLOCK IMPLANT
Applicant
Pillar Surgical, Inc.
P.O. Box 8141
La Jolla,  CA  92038
Applicant Contact ROB FRITZENKOTTER
Correspondent
Pillar Surgical, Inc.
P.O. Box 8141
La Jolla,  CA  92038
Correspondent Contact ROB FRITZENKOTTER
Regulation Number874.3620
Classification Product Code
JOF  
Date Received08/23/2000
Decision Date 11/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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