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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name curette, ear
510(k) Number K852039
Device Name FLEX-LOOP FLEXIBLE EAR CORETTE
Applicant
BIONIX CORP.
2140 OLD PLANKE RD.
HOLLAND,  OH  43528
Applicant Contact JAMES J HUTTNER
Correspondent
BIONIX CORP.
2140 OLD PLANKE RD.
HOLLAND,  OH  43528
Correspondent Contact JAMES J HUTTNER
Regulation Number874.4420
Classification Product Code
JYG  
Date Received05/09/1985
Decision Date 06/11/1985
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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