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FDA 510(k) Application Details - K022861
Device Classification Name
Sheet, Recording, Breast Examination
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510(K) Number
K022861
Device Name
Sheet, Recording, Breast Examination
Applicant
RUSIN MEDICAL DEVICES
3512 RUM RIVER DR.
ANOKA, MN 55303 US
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Contact
JAMES D RUSIN
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Regulation Number
884.2990
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Classification Product Code
NHM
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More FDA Info for this Product Code
Date Received
08/28/2002
Decision Date
11/26/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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