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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Disposable
510(k) Number K943229
Device Name DISPOSABLE SURGICAL SCISSORS AND FORCEPS
Applicant
Y.M.K. International Co., Ltd.
3f 2ln 200 Sec. 4, Chengkung
Rd.
Taipei,  TW
Applicant Contact Y. M KUNG
Correspondent
Y.M.K. International Co., Ltd.
3f 2ln 200 Sec. 4, Chengkung
Rd.
Taipei,  TW
Correspondent Contact Y. M KUNG
Regulation Number878.4800
Classification Product Code
KDC  
Date Received07/06/1994
Decision Date 08/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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