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FDA 510(k) Application Details - K223923
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K223923
Device Name
Laparoscope, General & Plastic Surgery
Applicant
KARL STORZ Endoscopy-America, Inc
2151 E. Grand Avenue
EL SEGUNDO, CA 90245 US
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Contact
Alita McElroy
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
12/30/2022
Decision Date
03/30/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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