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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 K931064
Device Name THE BLENDTONE EPILATOR
Applicant
Instantron
3124 Pawtucket Ave.
East Providence,  RI  02915
Applicant Contact STEPHEN A BONZAGNI
Correspondent
Instantron
3124 Pawtucket Ave.
East Providence,  RI  02915
Correspondent Contact STEPHEN A BONZAGNI
Regulation Number878.5350
Classification Product Code
KCW  
Date Received03/01/1993
Decision Date 07/08/1993
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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