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

BLOCKING TRAY

K Number: K023636 · Decision Nov 22, 2002
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
2
Review Days
23

Basic Information

Device Name
BLOCKING TRAY
K Number
K023636
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.5050
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
SOUTHEASTERN RADIATION PRODUCTS, INC.
Date Received
October 30, 2002
Decision Date
November 22, 2002
Product Code
IYE
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IYE Accelerator, Linear, Medical

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K Number Device Name
K040804 .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR