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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K952787
Device Name FOAM INSTRUMENT GUARD
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 Number880.6850
Classification Product Code
KCT  
Date Received06/19/1995
Decision Date 12/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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