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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K013212
Device Name WAVELENGHT ULTRASOUND LOTION
Applicant
NATIONAL THERAPY PRODUCTS INC.
2-191 ROWNTREE DAIRY RD.
WOODBRIDGE, ONTARIO,  CA LHL 8B8
Applicant Contact PAUL L HOOEY
Correspondent
NATIONAL THERAPY PRODUCTS INC.
2-191 ROWNTREE DAIRY RD.
WOODBRIDGE, ONTARIO,  CA LHL 8B8
Correspondent Contact PAUL L HOOEY
Regulation Number892.1570
Classification Product Code
MUI  
Date Received09/25/2001
Decision Date 02/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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