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510(k) K142792

AbbVie NJ by AbbVie, Inc. — Product Code KNT

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 14, 2015
Date Received
September 26, 2014
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 AbbVie, Inc.

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  • K142793 — AbbVie PEG (January 14, 2015)
  • K142816 — AbbVie J (January 14, 2015)
  • K133129 — ABBVIE NJ (June 19, 2014)
  • K133087 — ABBVIE PEG (June 19, 2014)
  • K133096 — ABB VIE J (June 18, 2014)

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  • K242901 — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN (January 10, 2025)
  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
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