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510(k) K903340

STERILE URETHRAL CATHETER PROCEDURE KITS by Superior Healthcare Group, Inc. — Product Code FCM

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
October 4, 1990
Date Received
July 25, 1990
Clearance Type
Traditional
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 Superior Healthcare Group, Inc.

  • K925530 — INSTRUMENT WARMER (June 18, 1993)
  • K924764 — OVERTUBE FOR ENDSCOPIC LIGATOR (March 15, 1993)
  • K905755 — NON-STERILE PATIENT EXAMINATION GLOVES (March 8, 1991)
  • K903347 — SODIUM CHLORIDE SOLUTION (December 13, 1990)
  • K904216 — STERILE WATER SOLUTION CATALOG # 10000 (November 16, 1990)
  • K896321 — NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. (November 13, 1989)
  • K894676 — STERILE LATEX EXAM GLOVES (August 17, 1989)
  • K891445 — LATEX EXAMINATION GLOVES (August 9, 1989)
  • K892426 — NO. 86500 - ENDOSCOPIC JET WASHER (June 22, 1989)
  • K885339 — FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT (March 1, 1989)

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  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
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  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)