FDA 510(k) Application Details - K961251

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K961251
Device Name Needle, Hypodermic, Single Lumen
Applicant BIO-PLEXUS, INC.
384 MERROW RD.
TOLLAND, CT 06084 US
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Contact CARL SAHI
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 04/01/1996
Decision Date 06/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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