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FDA 510(k) Application Details - K170703
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K170703
Device Name
Arthroscope
Applicant
Modern Medical Equipment Manufacturing Limited
35-41 Tai Lin Pai Rd, Unit F
5th Fl, Gold King Ind., Bldg., Kwai Chung, N.T.
Hong Kong CN
Other 510(k) Applications for this Company
Contact
Jerry Cheung
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/08/2017
Decision Date
05/31/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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