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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator, Therapeutic
510(k) Number K871107
Device Name VASOTRAIN 447
Applicant
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Applicant Contact HENLEY, DR
Correspondent
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Correspondent Contact HENLEY, DR
Regulation Number890.5975
Classification Product Code
IRO  
Date Received03/19/1987
Decision Date 05/29/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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