FDA 510(k) Application Details - K971645

Device Classification Name Needle, Spinal, Short Term

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510(K) Number K971645
Device Name Needle, Spinal, Short Term
Applicant AVID N.I.T., INC.
917 KLOSTERMAN RD. EAST
TARPON SPRINGS, FL 34689 US
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Contact JOSEPH E HARMS
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Regulation Number 868.5150

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Classification Product Code MIA
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Date Received 05/05/1997
Decision Date 08/01/1997
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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