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

SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET

K Number: K082710 · Decision Jan 23, 2009
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
1
Review Days
129

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Basic Information

Device Name
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET
K Number
K082710
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.5980
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Neochild, LLC
Date Received
September 16, 2008
Decision Date
January 23, 2009
Product Code
KNT
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
KNT Tubes, Gastrointestinal (And Accessories)

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