FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

MODIFIED EXTRAVAKIT

K Number: K882025 · Decision Jul 27, 1988
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
1
Review Days
71

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Basic Information

Device Name
MODIFIED EXTRAVAKIT
K Number
K882025
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5860
Medical Specialty
General Hospital
Decision
Unknown
Applicant
Extravakit, Inc.
Date Received
May 17, 1988
Decision Date
July 27, 1988
Product Code
FMF
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
FMF Syringe, Piston

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