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

STOPCOCKS

K Number: K851986 · Decision May 23, 1985
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
7
Review Days
16

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Basic Information

Device Name
STOPCOCKS
K Number
K851986
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Transamerica Delaval, Inc.
Date Received
May 7, 1985
Decision Date
May 23, 1985
Product Code
FMG
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
FMG Stopcock, I.V. Set

Similar 510(k) Clearances

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Other Clearances by Transamerica Delaval, Inc.

K Number Device Name
K853996 DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE
K851989 DOME, DISPOSABLE, STERILE
K851988 ADMINISTRATION SET
K851987 FLUSH DEVICE, AUTOMATIC
K833171 MONITORING KIT
K833170 FLUSH DEVICE