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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 K800018
Device Name BK-5203 FACILITATION VIBRATOR ELECTRIC
Applicant
Fred Sammons, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fred Sammons, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5975
Classification Product Code
IRO  
Date Received01/02/1980
Decision Date 01/21/1980
Decision Substantially Equivalent (SESE)
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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