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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K925729
Device Name SD-602 SD MODE 11, SD-603 SD MOD 111
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
GZJ  
Date Received11/13/1992
Decision Date 01/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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