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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rongeur, Manual
510(k) Number K200387
Device Name Ace Medical Surgical Instruments
Applicant
Ace Medical
2230 Park Ave. #202
Cincinnati,  OH  45206
Applicant Contact Alex Ebner
Correspondent
Jalex Medical
28765 Clemens Rd. Suite 3
Westlake,  OH  44145
Correspondent Contact Cassie Petrov
Regulation Number882.4840
Classification Product Code
HAE  
Date Received02/18/2020
Decision Date 07/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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