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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 K840753
Device Name AMBEZE DISPOSABLE INCONTINENCE PANTS
Applicant
IPCO CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
IPCO CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received02/23/1984
Decision Date 04/13/1984
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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