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510(k) K955155

DOCUMENT TDM ULTRA UNASSAYED CONTROL by Casco Standards — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1995
Date Received
November 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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