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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name barrier, synthetic, intraoral
510(k) Number K091120
Device Name MEDPOR CONTAIN 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 Number872.3930
Classification Product Code
NPK  
Date Received04/17/2009
Decision Date 03/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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