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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K231707
Device Name ResQ Administration Set
Applicant
Q For Plastic Industries
Land Plot #25,27.First Industrial Zone
Badr,  EG 11829
Applicant Contact Islam Nazieh Mohamed Ali
Correspondent
Global Quality and Regulatory Services
10 Scenic Way
Monroe,  NJ  08831
Correspondent Contact Abdel B Halim
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/12/2023
Decision Date 01/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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