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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 K943396
Device Name THE ELITE SPECTRUM
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
Regulation Number878.5350
Classification Product Code
KCW  
Date Received07/14/1994
Decision Date 09/16/1994
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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