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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light based imaging
510(k) Number K023729
Device Name SIASCOPE II
Applicant
ASTRON CLINICA LIMITED
PO BOX 4341
crofton,  MD  21114
Applicant Contact e.j. smith
Correspondent
ASTRON CLINICA LIMITED
PO BOX 4341
crofton,  MD  21114
Correspondent Contact e.j. smith
Regulation Number878.4580
Classification Product Code
PSN  
Date Received11/06/2002
Decision Date 02/03/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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