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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K905123
Device Name G-TUBE DRESSING CHANGE TRAY
Applicant
CONTINENTAL MEDICAL LABORATORIES, INC.
P.O. BOX 306
817 MOHR AVENUE
WATERFORD,  WI  53185
Applicant Contact JOSEPH DUNN
Correspondent
CONTINENTAL MEDICAL LABORATORIES, INC.
P.O. BOX 306
817 MOHR AVENUE
WATERFORD,  WI  53185
Correspondent Contact JOSEPH DUNN
Regulation Number880.5075
Classification Product Code
MCY  
Date Received11/14/1990
Decision Date 03/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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