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

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)

K Number: K952350 · Decision Jul 17, 1995
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
2
Applicant Total
5
Review Days
59

Basic Information

Device Name
JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
K Number
K952350
Device Class
FDA class 2
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
PROMEDICAL LTD.
Date Received
May 19, 1995
Decision Date
July 17, 1995
Product Code
LWE
Advisory Committee
Unknown
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
LWE Bone Marrow Collection/Transfusion Kit

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K944942 BREAST LESION LOCALIZATION NEEDLE