FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

INFANT FEEDING TUBE

K Number: K953008 · Decision Jan 11, 1996
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
17
Review Days
197

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Basic Information

Device Name
INFANT FEEDING TUBE
K Number
K953008
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.5980
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Marquette Medical, Inc.
Date Received
June 28, 1995
Decision Date
January 11, 1996
Product Code
FPD
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FPD Tube, Feeding

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Other Clearances by Marquette Medical, Inc.

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K920537 SUBCUTANEOUS INFUSION SET
K905218 4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP
K905219 4' LOW VOLUME IV EXTENSION SET
K905374 IV EXTENSION SETS WITH .22 MICRON FILTER
K901089 LOW VOLUME TRIFURCATED IV EXTENSION SET
K901088 LOW VOLUME BIFURCATED IV EXTENSION SET
K900427 IV TRIFURCATED EXTENSION SET
K900426 IV BIFURCATED EXTENSION SET
Search all 17 clearances from Marquette Medical, Inc. →