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510(k) K922402

4 SURE TM ENTERAL FEEDING BAG by Boston Pacific Medical, Inc. — Product Code FPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1994
Date Received
May 21, 1992
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 Boston Pacific Medical, Inc.

  • K933109 — 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS (March 28, 1994)
  • K931048 — 4-SURE NELATON CATHETER (February 14, 1994)
  • K931047 — 4-SURE FEMALE CATHETER (February 14, 1994)
  • K921852 — 4 SURE TM RECTAL TUBE (October 8, 1993)
  • K921853 — 4 SURE TM FEEDING TUBES (July 13, 1993)
  • K921851 — 4 SURE TM SUCTION CATHETERS & KITS (July 7, 1993)
  • K922398 — 4 SURE TM ENEMA BAG SET (June 17, 1993)
  • K922397 — 4 SURE TM NASAL OXYGEN CANNULA (March 18, 1993)
  • K924995 — 4 SURE TM ANESTHESIA EXTENSION SET (December 30, 1992)
  • K922401 — 4 SURE TM COLOSTOMY POUCH (June 10, 1992)

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)