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510(k) K101214

GUARDIAN CONNECTION by Maulin Medical, LLC — Product Code FPD

K101214 is an FDA 510(k) premarket notification submitted by Maulin Medical, LLC for the device "GUARDIAN CONNECTION". The FDA issued a decision of Substantially Equivalent on July 23, 2010. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2010
Date Received
April 30, 2010
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

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  • 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)
  • K100099 — ORAL/ENTERAL SYRINGES (June 14, 2010)
  • K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (April 22, 2010)

FDA data resources