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510(k) K950176

PREMIE U-BAG URINE SPECIMEN COLLECTOR by Hollister, Inc. — Product Code FOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
January 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Urine Collection, Newborn
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

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Other clearances for product code FOC

  • K943752 — RIMECO MIDSTREAM URINE COLLECTOR (November 1, 1994)
  • K911329 — BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE (May 28, 1991)
  • K771368 — PORTABLE INFANT VENTILATOR (August 4, 1977)