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510(k) K971901

RADIUS LOW PROFILE GASTROSTOMY TUBE KIT by Radius Intl., Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1998
Date Received
May 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Radius Intl., Inc.

  • K972025 — RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (January 23, 1998)
  • K972102 — RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (January 23, 1998)
  • K951560 — RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS) (April 17, 1995)
  • K930510 — RADIUS ENTERAL FEEDING TUBE (February 1, 1995)

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