FDA 510(k) Application Details - K961856

Device Classification Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

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510(K) Number K961856
Device Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact JANET G JOHNSON
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Regulation Number 880.5970

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Classification Product Code LJS
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Date Received 05/14/1996
Decision Date 07/18/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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