FDA 510(k) Application Details - K942073

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K942073
Device Name Needle, Hypodermic, Single Lumen
Applicant SUPERIOR DIAPERING PRODUCTS LTD.
BOX 1208
POINT ROBERTS, WA 98281 US
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Contact LYNN M CHASE
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 04/29/1994
Decision Date 02/29/1996
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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