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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Adhesive, Closure, Skin
510(k) Number K874813
Device Name OMED WOUND CLOSURE STRIPS
Applicant
Oxboro Medical Intl., Inc.
9635 Girard Ave. S.
Bloomington,  MN  55431
Applicant Contact KEVIN P MAXWELL
Correspondent
Oxboro Medical Intl., Inc.
9635 Girard Ave. S.
Bloomington,  MN  55431
Correspondent Contact KEVIN P MAXWELL
Regulation Number880.5240
Classification Product Code
FPX  
Date Received11/24/1987
Decision Date 01/29/1988
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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