FDA 510(k) Application Details - K170703

Device Classification Name Arthroscope

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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
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Contact Jerry Cheung
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Regulation Number 888.1100

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Classification Product Code HRX
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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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