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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 K221004
Device Name HOPKINS Telescopes
Applicant
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Applicant Contact Alita McElroy
Correspondent
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Correspondent Contact Alita McElroy
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/05/2022
Decision Date 12/20/2022
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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