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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K231519
Device Name Revital Cady
Applicant
Revital Healthcare (EPZ) Limited
LR NO. 5025/1239 Takaungu
Mombasa,  KE 80713-80100
Applicant Contact Ankur Vora
Correspondent
Alceon Medtech Consulting
1008, 10th Floor, “OCEAN”, Sarabhai Compound
Near Centre Square mall, Dr. V.S. Marg
Vadodara,  IN 390007
Correspondent Contact Atonu Dutta
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received05/25/2023
Decision Date 11/06/2023
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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