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FDA 510(k)

4 SURE TM ENTERAL FEEDING BAG

K-Number: K922402 · 1994-03-25

ApplicantBoston Pacific Medical, Inc.
Decision Date1994-03-25
Product CodeFPD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4 SURE TM ENTERAL FEEDING BAG is the device name listed in this FDA 510(k) record. The listed applicant is Boston Pacific Medical, Inc.. It received FDA 510(k) clearance on 1994-03-25 under 510(k) number K922402. The device is classified under product code FPD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4 SURE TM ENTERAL FEEDING BAG?

4 SURE TM ENTERAL FEEDING BAG is a medical device that received FDA 510(k) clearance on 1994-03-25. The listed applicant is Boston Pacific Medical, Inc.. The 510(k) number is K922402.

When did 4 SURE TM ENTERAL FEEDING BAG receive FDA 510(k) clearance?

4 SURE TM ENTERAL FEEDING BAG received FDA 510(k) clearance on 1994-03-25, under 510(k) number K922402.

Who is the listed applicant for 4 SURE TM ENTERAL FEEDING BAG?

The FDA 510(k) record lists Boston Pacific Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4 SURE TM ENTERAL FEEDING BAG?

The FDA product code for 4 SURE TM ENTERAL FEEDING BAG is FPD.

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Other records listing Boston Pacific Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K9331094SURE URO-LINK UROLOGICAL PROCEDURE TRAYSK9310474-SURE FEMALE CATHETERK9310484-SURE NELATON CATHETERK9218524 SURE TM RECTAL TUBEK9218534 SURE TM FEEDING TUBESK9218514 SURE TM SUCTION CATHETERS & KITS

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Related Devices (Code: FPD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243361NutrifitVygon USAK180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd.K131590INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBEPhilips Medical SystemsK120815INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBEPhilips Medical SystemsK121105NUTRISAFE 2 FEEDING TUBEVygon Corp.K100163NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXXVygon Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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