FDA 510(k) Application Details - K983858

Device Classification Name Needle, Spinal, Short Term

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510(K) Number K983858
Device Name Needle, Spinal, Short Term
Applicant SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE, NH 03431 US
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Contact TIMOTHY J TALCOTT
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Regulation Number 868.5150

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Classification Product Code MIA
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Date Received 11/02/1998
Decision Date 01/29/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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