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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name epilator, high frequency, needle-type
510(k) Number K954031
Device Name COMPU-BLEND EPILATOR
Applicant
R. A. FISCHER CO. CORP.
517 COMMERCIAL ST.
GLENDALE,  CA  91203
Applicant Contact MARK VAN ORDEN
Correspondent
R. A. FISCHER CO. CORP.
517 COMMERCIAL ST.
GLENDALE,  CA  91203
Correspondent Contact MARK VAN ORDEN
Regulation Number878.5350
Classification Product Code
KCW  
Date Received08/28/1995
Decision Date 01/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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