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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K213210
Device Name Oxygen Concentrator, Model JAY-5AW
Applicant
Longfian Scitech Co., Ltd.
2f&3f, E. Section, Bldg. 12, Power Valley Pioneer Park
#369 Huiyang St.
Baoding,  CN 071051
Applicant Contact Shi Lei
Correspondent
P&L Scientific, Inc.
1430 S Dixie Hwy. Suite 105
Coral Gables,  FL  33146
Correspondent Contact Jun Peng
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/29/2021
Decision Date 12/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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