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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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More FDA Info for this Product Code
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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