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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Iontophoresis, Other Uses
510(k) Number K946337
Device Name IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II
Applicant
Skylark Device Co., Ltd.
P.O. Box 68-502 Taipei
Taiwan, R.O.C.,  TW
Applicant Contact GEORGE K C. CHEN
Correspondent
Skylark Device Co., Ltd.
P.O. Box 68-502 Taipei
Taiwan, R.O.C.,  TW
Correspondent Contact GEORGE K C. CHEN
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received12/29/1994
Decision Date 12/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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