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510(k) K070879

BARD MALECOT AND PEZZER DRAINS by C.R. Bard, Inc. — Product Code FEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2007
Date Received
March 30, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Malecot
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

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Other clearances for product code FEW

  • K140085 — UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (November 18, 2014)
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  • K954147 — MANAN MALECOT BASKET DRAINAGE CATHETER (March 26, 1996)
  • K954116 — SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (November 6, 1995)
  • K920423 — OLYMPIC SMART SCALE CARE CENTER (June 11, 1992)