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510(k) K770826

POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE by Howmedica Corp. — Product Code FON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1977
Date Received
May 5, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Drainage, With Adhesive, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type

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  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
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  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)

Other clearances for product code FON

  • K801504 — HOLLISTER DRAINAGE POUCH (August 12, 1980)
  • K772366 — BAG, DRAINAGEW/ADHESIVE; PROSTHESIS (January 26, 1978)