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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
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