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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 K083621
Device Name MEDPOR CUSTOMIZED SURGICAL IMPLANT
Applicant
Porex Surgical, Inc.
15 Dart Rd.
Newnan,  GA  30265
Applicant Contact JERRI L MANN
Correspondent
Porex Surgical, Inc.
15 Dart Rd.
Newnan,  GA  30265
Correspondent Contact JERRI L MANN
Regulation Number874.3620
Classification Product Code
JOF  
Subsequent Product Code
GWO  
Date Received12/08/2008
Decision Date 02/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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