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

TRANSFER SET

K Number: K923782 · Decision Jul 2, 1993
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
5
Review Days
339

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Basic Information

Device Name
TRANSFER SET
K Number
K923782
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Pacific Device, Inc.
Date Received
July 28, 1992
Decision Date
July 2, 1993
Product Code
LHI
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
LHI Set, I.V. Fluid Transfer

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (LHI), ordered by most recent decision date.

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Other Clearances by Pacific Device, Inc.

K Number Device Name
K972464 VITALMIX PLUS EMPTY I.V. CONTAINER
K912860 INTRAVASCULAR ADMINISTRATION SETS
K912596 MECONIUM ASPIRATION
K902482 VITALMIX (SET & BAG)