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510(k) K772366

BAG, DRAINAGEW/ADHESIVE; PROSTHESIS by Atlantic Surgical — Product Code FON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1978
Date Received
December 27, 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

Other clearances by Atlantic Surgical

  • K820167 — LAMINATED KARAYA GUM WASHERS (February 18, 1982)
  • K770230 — KARAYA GUM POWDER (February 28, 1977)

Other clearances for product code FON

  • K801504 — HOLLISTER DRAINAGE POUCH (August 12, 1980)
  • K770826 — POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE (June 28, 1977)