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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 K946382
Device Name SKALPI 3200
Applicant
Wiscco Development, Inc.
12419 Huston St.
North Hollywood,  CA  91607
Applicant Contact GUSTAVO RABIN
Correspondent
Wiscco Development, Inc.
12419 Huston St.
North Hollywood,  CA  91607
Correspondent Contact GUSTAVO RABIN
Regulation Number890.5975
Classification Product Code
IRO  
Date Received12/14/1994
Decision Date 05/30/1995
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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