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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name scalpel, one-piece
510(k) Number K880028
Device Name OMED DISPOSABLE SCALPEL
Applicant
OXBORO MEDICAL INTL., INC.
9635 GIRARD AVE SOUTH
BLOOMINGTON,  MN  55431
Applicant Contact KEVIN P MAXWELL
Correspondent
OXBORO MEDICAL INTL., INC.
9635 GIRARD AVE SOUTH
BLOOMINGTON,  MN  55431
Correspondent Contact KEVIN P MAXWELL
Regulation Number878.4800
Classification Product Code
GDX  
Date Received01/05/1988
Decision Date 01/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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