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510(k) K864683

NEONATAL FEEDING KIT by Salt Creek Medical Technologies — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1987
Date Received
December 2, 1986
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 Salt Creek Medical Technologies

  • K871042 — URINE METER, 250CC (March 25, 1987)
  • K871075 — SCMT UMBILICAL CLAMP (March 23, 1987)
  • K871087 — S.C.M.T. PERFORATOR (March 23, 1987)
  • K864296 — S.C.T. MULTI PORT, INJECTION SITE (March 2, 1987)
  • K864682 — SALT CREEK P.I. TRAY (January 6, 1987)
  • K864692 — EXTENSION SETS (December 18, 1986)
  • K864693 — I.V. START KITS (December 16, 1986)

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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)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)