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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 K180977
Device Name KARL STORZ New Generation Trocars
Applicant
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Applicant Contact AnnaLisa Smullin
Correspondent
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Correspondent Contact AnnaLisa Smullin
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/13/2018
Decision Date 07/18/2018
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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