FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

CONOD Enteral Feeding Sets

K Number: K181276 · Decision Jul 12, 2018
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
49
Applicant Total
2
Review Days
59

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Basic Information

Device Name
CONOD Enteral Feeding Sets
K Number
K181276
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.5980
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Conod Medical Co., Limited
Date Received
May 14, 2018
Decision Date
July 12, 2018
Product Code
PIF
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
PIF Gastrointestinal Tubes With Enteral Specific Connectors

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K Number Device Name
K203591 Single-use Medical Face Mask