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510(k) K801504

HOLLISTER DRAINAGE POUCH by Hollister, Inc. — Product Code FON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1980
Date Received
June 27, 1980
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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Other clearances for product code FON

  • K772366 — BAG, DRAINAGEW/ADHESIVE; PROSTHESIS (January 26, 1978)
  • K770826 — POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE (June 28, 1977)