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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ent Manual Surgical
510(k) Number K873044
Device Name POREX OTOLOGY INSTRUMENTS
Applicant
Porex Medical
500 Bohannon Rd.
Fairburn,  GA  30213
Applicant Contact HOWARD A MERCER,PHD
Correspondent
Porex Medical
500 Bohannon Rd.
Fairburn,  GA  30213
Correspondent Contact HOWARD A MERCER,PHD
Regulation Number874.4420
Classification Product Code
LRC  
Date Received08/04/1987
Decision Date 09/04/1987
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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