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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name interferential current therapy
510(k) Number K974585
Device Name IF-727 INTERFERENTIAL STIMULATOR
Applicant
SKYLARK DEVICE CO., LTD.
34 CHUNG SHAN NORTH RD.,
12TH FL., SEC. 3
TAIPEI,  TW
Applicant Contact GEORGE K.C. CHEN
Correspondent
SKYLARK DEVICE CO., LTD.
34 CHUNG SHAN NORTH RD.,
12TH FL., SEC. 3
TAIPEI,  TW
Correspondent Contact GEORGE K.C. CHEN
Regulation Number882.5890
Classification Product Code
LIH  
Date Received12/08/1997
Decision Date 03/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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