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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 K221957
Device Name Savewo ClassicMASK
Applicant
Savewo Limited
1/F & 2/F, 266-270 Texaco Rd., Tsuen Wan
Hong Kong,  CN 0000
Applicant Contact Melanie Choi
Correspondent
Long Jing Technology , Ltd.
17th Chung Pont Commercial Bldg., 300 Hennessy Rd.
Hong Kong,  CN 0000
Correspondent Contact Ivy Lai
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/05/2022
Decision Date 09/02/2022
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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