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FDA 510(k) Application Details - K981449
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K981449
Device Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant
SKYLARK DEVICE CO., LTD.
34 CHUNG SHAN NORTH RD.,
12TH FL., SEC. 3
TAIPEI TW
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Contact
GEORGE K C CHEN
Other 510(k) Applications for this Contact
Regulation Number
890.5300
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Classification Product Code
IMI
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More FDA Info for this Product Code
Date Received
04/22/1998
Decision Date
12/11/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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