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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 K954203
Device Name MASSAGER THERAPUTIC, ELECTRIC
Applicant
Cisco Sales Corp.
23775 Madison St.
Torrance,  CA  90505
Applicant Contact NEIL J KAY
Correspondent
Cisco Sales Corp.
23775 Madison St.
Torrance,  CA  90505
Correspondent Contact NEIL J KAY
Regulation Number890.5975
Classification Product Code
IRO  
Date Received09/07/1995
Decision Date 12/11/1995
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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