FDA 510(k) Application Details - K972521

Device Classification Name Stylet, Surgical, General & Plastic Surgery

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510(K) Number K972521
Device Name Stylet, Surgical, General & Plastic Surgery
Applicant SIL-MED CORP.
700 WARNER BLVD.
TAUNTON, MA 02780 US
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Contact KAREN K SYLVIA
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Regulation Number 878.4800

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Classification Product Code GAH
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Date Received 07/07/1997
Decision Date 10/01/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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