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510(k) K871789

INTECARE PEDIATRIC URINE COLLECTOR by Mercury Enterprises, Inc. — Product Code FFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1987
Date Received
May 6, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, Pediatric, For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Mercury Enterprises, Inc.

  • K885342 — GENNY DENNY IV SHIELD (March 30, 1989)
  • K862722 — TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE (August 11, 1986)

Other clearances for product code FFH

  • K905016 — PEDIATRIC AND INFANT CATH KITS (December 20, 1990)
  • K896581 — PEDIATRIC DRAIN BAG (January 31, 1990)