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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sheet, recording, breast examination
510(k) Number K022861
Device Name SAFETOUCH
Applicant
RUSIN MEDICAL DEVICES
3512 RUM RIVER DR.
ANOKA,  MN  55303
Applicant Contact JAMES D RUSIN
Correspondent
RUSIN MEDICAL DEVICES
3512 RUM RIVER DR.
ANOKA,  MN  55303
Correspondent Contact JAMES D RUSIN
Regulation Number884.2990
Classification Product Code
NHM  
Date Received08/28/2002
Decision Date 11/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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