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510(k) K023662

PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER by Hwadong International Company , Ltd. — Product Code MCF

K023662 is an FDA 510(k) premarket notification submitted by Hwadong International Company , Ltd. for the device "PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER". The FDA issued a decision of Substantially Equivalent on May 28, 2003. The device falls under product code MCF (Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile), a Class I device regulated under 21 CFR 872.6855.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2003
Date Received
October 31, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Device Class
Class I
Regulation Number
872.6855
Review Panel
DE
Submission Type

Other clearances for product code MCF

  • K021258 — GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER (May 10, 2002)
  • K003517 — OTRES TOOTHBRUSH SANITIZER MODEL TB100W (June 6, 2001)
  • K901459 — DS60 TOOTHBRUSH SANITIZER (September 17, 1990)
  • K896481 — PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER (May 15, 1990)

FDA data resources