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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K863281
Device Name CARE + PLUS IRREGATION TRAY
Applicant
WELMED SYSTEMS, INC.
P.O. BOX 599
WEST SWANZEY,  NH  03469
Applicant Contact DAVID B PETERS
Correspondent
WELMED SYSTEMS, INC.
P.O. BOX 599
WEST SWANZEY,  NH  03469
Correspondent Contact DAVID B PETERS
Regulation Number876.5130
Classification Product Code
KOD  
Date Received08/25/1986
Decision Date 10/31/1986
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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