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510(k) K952611

STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION by Sterex Electrolysis Intl., Ltd. — Product Code KCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1995
Date Received
June 7, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epilator, High Frequency, Needle-Type
Device Class
Class I
Regulation Number
878.5350
Review Panel
SU
Submission Type

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  • K943398 — THE BLENDTONE ROYALE (September 16, 1994)
  • K941227 — SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL (August 18, 1994)
  • K931063 — THE ELITE EPILATOR (July 8, 1993)
  • K931062 — THE VP500 EPILATOR (July 8, 1993)
  • K931064 — THE BLENDTONE EPILATOR (July 8, 1993)