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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Disposable
510(k) Number K820161
Device Name AXIOM LIG-A-BOOTS
Applicant
Axiom Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Axiom Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
KDC  
Date Received01/20/1982
Decision Date 03/15/1982
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
Predetermined Change
Control Plan Authorized		 No
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