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FDA 510(k) Application Details - K050410
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
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510(K) Number
K050410
Device Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant
HWANG SUN ENTERPRISE CO., LTD.
11 HEATHER COURT
MIDDLE ISLAND, NY 11953 US
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Contact
SING-HONG YEUNG
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
02/17/2005
Decision Date
07/14/2005
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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