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510(k) K964771

DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 by Dyna-Tek Industries — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1997
Date Received
November 27, 1996
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

Other clearances by Dyna-Tek Industries

  • K904326 — DE-TOX TUBES A AND DE-TOX TUBES B (January 17, 1991)

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