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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 K903098
Device Name MINI-VIBRATOR
Applicant
Frank J. Biehl
187 Stauffer Blvd.
San Jose,  CA  95125
Applicant Contact MICHAEL CHRISTY
Correspondent
Frank J. Biehl
187 Stauffer Blvd.
San Jose,  CA  95125
Correspondent Contact MICHAEL CHRISTY
Regulation Number890.5975
Classification Product Code
IRO  
Date Received07/13/1990
Decision Date 07/25/1990
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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