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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Suturing, Disposable
510(k) Number K012199
Device Name DIGICAP
Applicant
Humana USA, Inc.
8309 Bryant Dr.
Bethesda,  MD  20817
Applicant Contact H.N. DUNNING
Correspondent
Humana USA, Inc.
8309 Bryant Dr.
Bethesda,  MD  20817
Correspondent Contact H.N. DUNNING
Regulation Number878.4800
Classification Product Code
GAB  
Subsequent Product Code
KGO  
Date Received07/13/2001
Decision Date 12/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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