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510(k) K860818

ONE TIME ENTERAL FEEDING BAG by Acme United Corp. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1986
Date Received
March 4, 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 Acme United Corp.

  • K961323 — LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING (June 19, 1996)
  • K961452 — LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING (May 31, 1996)
  • K952565 — LYOFOAM EXTRA (November 14, 1995)
  • K895764 — MODIFIED LYOFOAM WOUND DRESSINGS (September 10, 1990)
  • K871740 — LYOSHEET SURGICAL SHEET FOR BURNS (June 9, 1987)
  • K864084 — LYOFOAM C ODOR-ABSORBING DRESSING (November 21, 1986)
  • K860085 — LYOFOAM WOUND DRESSINGS (June 27, 1986)
  • K861015 — ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS (April 22, 1986)
  • K842186 — ACU-DERM TRANSPARENT WOUND DRESSING (August 24, 1984)
  • K842064 — ACU-DERM TRANSPARENT IV DRESSING (August 15, 1984)

Other clearances for product code KNT

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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)