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

N.S. CADEE

K Number: K881785 · Decision May 31, 1988
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
1
Review Days
35

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
N.S. CADEE
K Number
K881785
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5570
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
First Scientific, Div.
Date Received
April 26, 1988
Decision Date
May 31, 1988
Product Code
FMI
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
FMI Needle, Hypodermic, Single Lumen

Similar 510(k) Clearances

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

View all