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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 -5195
Applicant Contact stephen a bonzagni
Correspondent
INSTANTRON
3124 PAWTUCKET AVE.
east providence,  RI  02915 -5195
Correspondent Contact stephen a bonzagni
  No 510(k) holder with active listings identified
Current 510(k) Holder
No 510(k) holder with active listings identified
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
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