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FDA 510(k) Application Details - K192891
Device Classification Name
Laparoscope, General & Plastic Surgery
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510(K) Number
K192891
Device Name
Laparoscope, General & Plastic Surgery
Applicant
Medeon Biodesign, Inc
7F, 116 Hougang St.,
Taipei 11170 TW
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Contact
Tsung-Yu Hsieh
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
10/10/2019
Decision Date
11/07/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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