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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 K102184
Device Name MEDPOR CONTAIN CAN IMPLANT
Applicant
POREX SURGICAL, INC.
15 DART RD.
NEWNAN,  GA  30265
Applicant Contact STEPHANIE FULLARD
Correspondent
POREX SURGICAL, INC.
15 DART RD.
NEWNAN,  GA  30265
Correspondent Contact STEPHANIE FULLARD
Regulation Number872.3930
Classification Product Code
NPK  
Date Received08/02/2010
Decision Date 01/07/2011
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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