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510(k) K870623

ENTERAL ADMINISTRATION SET by Plasco, Inc. — Product Code FPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1987
Date Received
February 12, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Plasco, Inc.

  • K980066 — CPR FILTERSHIELD (July 16, 1998)
  • K953414 — CPR MICROMASK WITH OXYGEN INLET (March 20, 1996)
  • K951483 — CPR MICROMASK (October 19, 1995)
  • K950770 — CPR MICROSHIELD II (March 10, 1995)
  • K950769 — CPR MICROMASK PLUS CATALOG NO 73-402 (March 10, 1995)
  • K943386 — CPR MICROMASK (February 21, 1995)
  • K932649 — PHARMAFEED (November 16, 1993)
  • K880337 — MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 (April 14, 1988)
  • K870796 — MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY (April 1, 1987)
  • K870019 — THE LAHR BALLOON (April 1, 1987)

Other clearances for product code FPD

  • K243361 — Nutrifit (December 19, 2024)
  • K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (January 18, 2019)
  • K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (October 23, 2013)
  • K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (March 6, 2013)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • K110853 — VR MEDICAL ENTERAL ORAL SYRINGE (May 13, 2011)
  • K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (December 13, 2010)
  • K101214 — GUARDIAN CONNECTION (July 23, 2010)
  • K100099 — ORAL/ENTERAL SYRINGES (June 14, 2010)