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510(k) K021258

GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER by Germ Terminator Corporation — Product Code MCF

K021258 is an FDA 510(k) premarket notification submitted by Germ Terminator Corporation for the device "GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER". The FDA issued a decision of Substantially Equivalent on May 10, 2002. 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 10, 2002
Date Received
April 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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

  • K023662 — PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER (May 28, 2003)
  • 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