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510(k) K852170

EZX YELLOW, BLUE OR ORANGE by Strong Marketing — Product Code EGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1985
Date Received
May 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Film, X-Ray
Device Class
Class I
Regulation Number
872.1905
Review Panel
DE
Submission Type

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  • K813378 — UNI-BITE DENTAL X-RAY FILM HOLDER (January 29, 1982)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)