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

VARIOUS TUBING

K Number: K943206 · Decision Mar 9, 1995
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
63
Applicant Total
7
Review Days
247

Basic Information

Device Name
VARIOUS TUBING
K Number
K943206
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
PRN SERVICES, INC.
Date Received
July 5, 1994
Decision Date
March 9, 1995
Product Code
FPK
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
FPK Tubing, Fluid Delivery

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