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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name arthroscope
510(k) Number K170703
Device Name Single Use Arthroscopic Electrode (with Pencil)
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
Applicant Contact Jerry Cheung
Correspondent
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
Correspondent Contact Jerry Cheung
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/08/2017
Decision Date 05/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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