FDA 510(k) Application Details - K955463

Device Classification Name Guard, Instrument

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510(K) Number K955463
Device Name Guard, Instrument
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 000.0000

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Classification Product Code LXZ
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Date Received 11/29/1995
Decision Date 01/23/1996
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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