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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K192310
Device Name Flap Fixator, Burr Hole Cover
Applicant
Ossaware Biotech Co., Ltd.
# 51, Xinggong Rd.
Shenkang Hsiang,  TW 50971
Applicant Contact Meng Feng Huang
Correspondent
Ossaware Biotech Co., Ltd.
# 51, Xinggong Rd.
Shenkang Hsiang,  TW 50971
Correspondent Contact Meng Feng Huang
Regulation Number882.5250
Classification Product Code
GXR  
Date Received08/26/2019
Decision Date 06/03/2020
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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