FDA 510(k) Application Details - K955250

Device Classification Name Vibrator, Therapeutic

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510(K) Number K955250
Device Name Vibrator, Therapeutic
Applicant EAST HEALTH DEVELOPMENT GROUP, INC.
P.O. BOX 947
TUSTIN, CA 92680 US
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Contact XIAOMING WANG
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Regulation Number 890.5975

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Classification Product Code IRO
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Date Received 11/13/1995
Decision Date 02/08/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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