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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 K223923
Device Name HOPKINS Telescopes
Applicant
KARL STORZ Endoscopy-America, Inc
2151 E. Grand Avenue
EL SEGUNDO,  CA  90245
Applicant Contact Alita McElroy
Correspondent
KARL STORZ Endoscopy-America, Inc
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Alita McElroy
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/30/2022
Decision Date 03/30/2023
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
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