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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K210864
Device Name Safety Pen Needle
Applicant
Sandstone Medical (Suzhou), Inc.
#168 Putuoshan Rd.
New District
Suzhou,  CN 215153
Applicant Contact Juanjuan Sun
Correspondent
Shenzhen Joyantech Consulting Co. , Ltd.
1713a, 17th Floor, Block A
Zhongguan Times Square Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Grace Liu
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/23/2021
Decision Date 02/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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