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510(k) K012070

ORALLITE COMPREHENSIVE EXAM TRAY by Trylon Corp. — Product Code MPU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2001
Date Received
July 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Chemiluminescent Light
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K963391 — SPECULITE (December 12, 1997)
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  • K953364 — SPECULITE (December 8, 1995)

Other clearances for product code MPU

  • K963391 — SPECULITE (December 12, 1997)