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510(k) K990428

DRAINAGE BAG by Remington Medical, Inc. — Product Code EXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1999
Date Received
February 11, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Bile Collecting
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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Other clearances for product code EXF

  • K003078 — MERIT DRAINAGE DEPOT (December 11, 2000)
  • K980005 — MANAN D BAG (January 30, 1998)
  • K961986 — MANAN D BAG (March 13, 1997)
  • K963849 — MANAN D BAG (December 13, 1996)
  • K943663 — NAVARRE 600 ML DRAINAGE BAG (September 8, 1994)
  • K911129 — MMG BILE BAG (August 7, 1991)
  • K903449 — URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET (September 12, 1990)
  • K901844 — URESIL TRU-CLOSE DRAINAGE BAG (June 1, 1990)