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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K943991
Device Name O-R-EZ TIP CLEANER
Applicant
O-R-Ez, Inc.
3930 Virginia Ave.
Cincinnati,  OH  45227
Applicant Contact GALE W MILLER
Correspondent
O-R-Ez, Inc.
3930 Virginia Ave.
Cincinnati,  OH  45227
Correspondent Contact GALE W MILLER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/16/1994
Decision Date 09/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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