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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 K854729
Device Name ADAM (ABSORBENT INCONTINENCE SHIELD)
Applicant
Lic-Orthion
Rodney R. Munsey
2101 L St. NW
Washington,  DC  20037
Applicant Contact C/ODICKSTEIN SHAPIRO
Correspondent
Lic-Orthion
Rodney R. Munsey
2101 L St. NW
Washington,  DC  20037
Correspondent Contact C/ODICKSTEIN SHAPIRO
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
Predetermined Change
Control Plan Authorized		 No
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