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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 K241426
Device Name GPS Advanced; 5 cc GPS Advanced Cannula
Applicant
Prosidyan, Inc.
41 Spring St. #107
New Providence,  NJ  07974
Applicant Contact Tamala Wampler
Correspondent
Depuy Synthes
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Karin McDonough
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/20/2024
Decision Date 07/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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