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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 K881276
Device Name HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS
Applicant
Ime Co. , Ltd.
1775 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact KEVIN G MCANANEY
Correspondent
Ime Co. , Ltd.
1775 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact KEVIN G MCANANEY
Regulation Number878.5350
Classification Product Code
KCW  
Date Received03/25/1988
Decision Date 05/04/1988
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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