FDA 510(k) Application Details - K964060

Device Classification Name Syringe, Piston

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510(K) Number K964060
Device Name Syringe, Piston
Applicant TRAVENOL LABORATORIES (ISRAEL) LTD.
INDUSTRIAL ZONE
KIRIAT SHMONA IL
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Contact HARRY LEINWAND
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 10/09/1996
Decision Date 12/24/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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