FDA 510(k) Application Details - K760780

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K760780
Device Name Needle, Hypodermic, Single Lumen
Applicant TRAVENOL LABORATORIES, S.A.


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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 10/05/1976
Decision Date 11/16/1976
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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