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510(k) K190414

Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV by Moss Tubes, Inc. — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2019
Date Received
February 21, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Tubes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To facilitate enteral specific connections.

Other clearances by Moss Tubes, Inc.

  • K990389 — MOSS GASTROSTOMY TUBE (March 22, 1999)
  • K984628 — MODIFICATION OF MOSS P.E.G. TRAY (March 17, 1999)
  • K984629 — MOSS TUBES, INC. NASAL TUBE - MARK IV (March 2, 1999)
  • K984310 — MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE (February 24, 1999)

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