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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name replacement, ossicular prosthesis, total
510(k) Number K884884
Device Name OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
Applicant
POREX TECHNOLOGIES CORP. OF GEORGIA
500 BOHANNON RD.
FAIRBURN,  GA  30213
Applicant Contact HOWARD A MERCER,PHD
Correspondent
POREX TECHNOLOGIES CORP. OF GEORGIA
500 BOHANNON RD.
FAIRBURN,  GA  30213
Correspondent Contact HOWARD A MERCER,PHD
Regulation Number874.3495
Classification Product Code
ETA  
Date Received11/22/1988
Decision Date 06/16/1989
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
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