FDA 510(k) Application Details - K962849

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

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510(K) Number K962849
Device Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant MEDCARE MEDICAL GROUP, INC.
234 OLD HOMESTEAD HWY.
EAST SWANZEY, NH 03446 US
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Contact CRAIG J BELL
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Regulation Number 880.5970

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Classification Product Code LJS
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Date Received 07/22/1996
Decision Date 10/07/1996
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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