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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 K822530
Device Name MULTIPLE, ENT CHAIR #418
Applicant
MIDMARK CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MIDMARK CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.5300
Classification Product Code
ETF  
Date Received08/23/1982
Decision Date 09/14/1982
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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