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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Surgical
510(k) Number K952783
Device Name OXBORO-MEDICAL PIN COVERS
Applicant
Oxboro Medical Intl., Inc.
13828 Lincoln St. NE
Ham Lake,  MN  55304
Applicant Contact HARLEY HAASE
Correspondent
Oxboro Medical Intl., Inc.
13828 Lincoln St. NE
Ham Lake,  MN  55304
Correspondent Contact HARLEY HAASE
Regulation Number888.3030
Classification Product Code
LRN  
Date Received06/19/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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