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510(k) K120272

AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET by Kentec Medical, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2012
Date Received
January 30, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Kentec Medical, Inc.

  • K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (April 22, 2010)
  • K050443 — ACCU-LEAD (September 2, 2005)
  • K970686 — ACCUTEMP-PROBE (August 25, 1997)
  • K960080 — ACCUTEMP PROBE (May 1, 1996)
  • K853475 — GRAM-MA NEONATAL SC (September 5, 1985)

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