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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
Predetermined Change
Control Plan Authorized		 No
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