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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K232968
Device Name Grande Medical Masks, Model SF-600
Applicant
Golden Grande Corp.
# 622-6, Guanghua Li, Xuejia Dist.
Tianan,  TW 72651
Applicant Contact Hsin Hui Tseng
Correspondent
Voler Biotech Consulting CO., Ltd.
1f., # 3-1, Ln. 58, Hejiang St., Zhongshan Dist.
Taipei City,  TW 104
Correspondent Contact Tyra Chiu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/21/2023
Decision Date 06/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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