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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K944596
Device Name GRAHAM-FIELD ULTRASOUND LOTION
Applicant
Chester Labs, Inc.
3208 Dixie Hwy.
Erlanger,  KY  41018
Applicant Contact VERA PRACHT
Correspondent
Chester Labs, Inc.
3208 Dixie Hwy.
Erlanger,  KY  41018
Correspondent Contact VERA PRACHT
Regulation Number890.5300
Classification Product Code
IMI  
Date Received09/19/1994
Decision Date 06/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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