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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name garment, protective, for incontinence
510(k) Number K854730
Device Name DAISY (ABSORBENT INCONTINENCE SHIELD)
Applicant
LIC-ORTHION
RODNEY R. MUNSEY
2101 L STREET N.W.
WASHINGTON,  DC  20037
Correspondent
LIC-ORTHION
RODNEY R. MUNSEY
2101 L STREET N.W.
WASHINGTON,  DC  20037
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received11/25/1985
Decision Date 02/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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