FDA 510(k) Substantially Equivalent 🇺🇸 United States

OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY

K Number: K837443 · Decision Jun 10, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
1
Review Days
42

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Basic Information

Device Name
OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY
K Number
K837443
Clearance Type
Traditional
Decision
Substantially Equivalent
Applicant
Medical Diagnostic Instruments, Inc.
Date Received
April 29, 1983
Decision Date
June 10, 1983
Advisory Committee
Unknown
Review Advisory Committee
RA
Third Party
N