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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K980002
Device Name KOALA VASCULAR CLAMPS AND INSERTS
Applicant
Boss Instruments, Ltd.
1310 Central Ct.
Hermitage,  TN  37076
Applicant Contact BURNS PHILLIPS
Correspondent
Boss Instruments, Ltd.
1310 Central Ct.
Hermitage,  TN  37076
Correspondent Contact BURNS PHILLIPS
Regulation Number870.4450
Classification Product Code
DXC  
Date Received01/02/1998
Decision Date 06/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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