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510(k) K896581

PEDIATRIC DRAIN BAG by Laytech Medical Co. — Product Code FFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1990
Date Received
November 17, 1989
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 Laytech Medical Co.

  • K893827 — PEAK FLOW RATE METER (August 11, 1989)

Other clearances for product code FFH

  • K905016 — PEDIATRIC AND INFANT CATH KITS (December 20, 1990)
  • K871789 — INTECARE PEDIATRIC URINE COLLECTOR (August 10, 1987)