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FDA 510(k) Application Details - K221642
Device Classification Name
Laparoscope, Gynecologic (And Accessories)
More FDA Info for this Device
510(K) Number
K221642
Device Name
Laparoscope, Gynecologic (And Accessories)
Applicant
Precision Robotics (Hong Kong) Limited
Suite 611-612 Lakeside 2, 10W,
Hong Kong Science Park,New Territories
Hong Kong 0000 CN
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Contact
Ping Lai Benny Lo
Other 510(k) Applications for this Contact
Regulation Number
884.1720
More FDA Info for this Regulation Number
Classification Product Code
HET
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/06/2022
Decision Date
12/12/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
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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