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510(k) K780735

URINARY CATHETER CARE SET by Shield Laboratories, Inc. — Product Code FCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1978
Date Received
May 1, 1978
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 Shield Laboratories, Inc.

  • K771712 — CATHETER DRESSING CHANCE SET (October 13, 1977)

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  • 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)