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510(k) K070939

SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM by Coloplast Manufacturing Us, LLC — Product Code FCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2007
Date Received
April 4, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Coloplast Manufacturing Us, LLC

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  • K082640 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM (October 17, 2008)

Other clearances for product code FCM

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  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)
  • K002803 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT (December 27, 2000)