FDA 510(k) Application Details - K040798

Device Classification Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K040798
Device Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant	HWANG SUN ENTERPRISE CO., LTD. 30 NORTHPORT ROAD SOUND BEACH, NY 11789 US Other 510(k) Applications for this Company
Contact	RICHARD C LANZILLOTTO Other 510(k) Applications for this Contact
Regulation Number	890.5300   More FDA Info for this Regulation Number
Classification Product Code	IMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2004
Decision Date	08/04/2004
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