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510(k) K830989

BAKER JEJUNOSTOMY TUBE by Medovations, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1983
Date Received
March 29, 1983
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

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  • K924646 — OVER THE GUIDEWIRE DILATATION SYSTEM (December 5, 1994)
  • K913678 — TROCAR CATHETER (December 16, 1991)
  • K905478 — YANKAUER SUCTION DEVICE (December 19, 1990)
  • K874309 — URETHAL CATHETER (December 7, 1987)
  • K864963 — STOMACH EVACULATOR - EWALD STYLE (October 14, 1987)
  • K864962 — OBERTO MOUTH PROP (February 19, 1987)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)

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  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
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