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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 K930535
Device Name IF400
Applicant
SKYLARK DEVICE CO., LTD.
12 FL. 34, SEC. 3 CHUNG SHAN
N. RD.
TAIPEI, TAIWAN, R.O.C.,  TW
Applicant Contact CHEN
Correspondent
SKYLARK DEVICE CO., LTD.
12 FL. 34, SEC. 3 CHUNG SHAN
N. RD.
TAIPEI, TAIWAN, R.O.C.,  TW
Correspondent Contact CHEN
Regulation Number882.5890
Classification Product Code
LIH  
Date Received02/02/1993
Decision Date 06/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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