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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K221042
Device Name Renova RP Centesis Pump
Applicant
GI Supply, Inc.
5069 Ritter Road Suite 104
Mechanicsburg,  PA  17055
Applicant Contact Erika Parry
Correspondent
GI Supply, Inc.
5069 Ritter Road Suite 104
Mechanicsburg,  PA  17055
Correspondent Contact Thomas Saladin
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/08/2022
Decision Date 04/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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