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510(k) K003517

OTRES TOOTHBRUSH SANITIZER MODEL TB100W by Otres, LLC — Product Code MCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
November 14, 2000
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

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  • K901459 — DS60 TOOTHBRUSH SANITIZER (September 17, 1990)
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