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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 K884079
Device Name MODEL CBX EPILATOR
Applicant
R. A. Fischer Co. Corp.
517 Commercial St.
Glendale,  CA  91203
Applicant Contact VAN ORDEN
Correspondent
R. A. Fischer Co. Corp.
517 Commercial St.
Glendale,  CA  91203
Correspondent Contact VAN ORDEN
Regulation Number878.5350
Classification Product Code
KCW  
Date Received09/27/1988
Decision Date 10/04/1988
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
Predetermined Change
Control Plan Authorized		 No
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