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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K241796
Device Name TroCare TroKit Laparoscope Lens Wiper (CP000626)
Applicant
TroCare, LLC
1000 Louisiana St.
Fifty Third Floor
Houston,  TX  77002
Applicant Contact Kenneth Kleinhenz
Correspondent
QSR Consulting
4141 Elm Rd.
Hudson,  MI  49247
Correspondent Contact Kenneth Kleinhenz
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/21/2024
Decision Date 10/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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