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510(k) K972102

RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT by Radius Intl., Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1998
Date Received
June 4, 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)
  • K971901 — RADIUS LOW PROFILE GASTROSTOMY TUBE KIT (January 22, 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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