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FDA 510(k) Application Details - K961295
Device Classification Name
Catheter, Irrigation
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510(K) Number
K961295
Device Name
Catheter, Irrigation
Applicant
SIL-MED CORP.
700 WARNER BLVD.
TAUNTON, MA 02780 US
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Contact
KAREN K SYLVIA
Other 510(k) Applications for this Contact
Regulation Number
878.4200
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Classification Product Code
GBX
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More FDA Info for this Product Code
Date Received
04/04/1996
Decision Date
06/26/1996
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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