FDA 510(k) Application Details - K812050

Device Classification Name Antiserum, Gentamicin

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510(K) Number K812050
Device Name Antiserum, Gentamicin
Applicant KALLESTAD LABORATORIES, INC.

, US
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Regulation Number 862.3450

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Classification Product Code DJI
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Date Received 07/21/1981
Decision Date 08/03/1981
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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