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510(k) K934142

URINARY DRAINAGE BAG by Key Medical Services, Inc. — Product Code EXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1994
Date Received
August 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinometer, Mechanical
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

Other clearances by Key Medical Services, Inc.

  • K951597 — URINARY DRAINAGE BAG (August 4, 1995)

Other clearances for product code EXR

  • K935578 — URINE METER (December 17, 1993)
  • K911258 — KENDALL PEDIATRIC URINE METER (April 25, 1991)
  • K896732 — UNOMETER 500 (November 2, 1990)
  • K870240 — COMPRESS AND SKULLCAP, HEAD DRESSING (February 20, 1987)
  • K771561 — DOVER URINE METER (September 7, 1977)
  • K770423 — URINE TESTER, MODEL NO. 707 (June 3, 1977)
  • K770939 — URINE TESTER, MODEL 701 (June 3, 1977)
  • K761083 — BARD URINE METER W/ BAG (January 26, 1977)