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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Examining/Treatment, Ent
510(k) Number K910781
Device Name #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
Applicant
Midmark Corp.
60 Vista Dr.
P.O. Box 286
Versailles,  OH  45380
Applicant Contact JOHN OLDIGES
Correspondent
Midmark Corp.
60 Vista Dr.
P.O. Box 286
Versailles,  OH  45380
Correspondent Contact JOHN OLDIGES
Regulation Number874.5300
Classification Product Code
ETF  
Date Received02/25/1991
Decision Date 05/15/1991
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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