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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K864529
Device Name LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
Applicant
Elof Hansson, Inc.
25 Van Zant St.
Norwalk,  CT  06855
Applicant Contact GAY CLARKE
Correspondent
Elof Hansson, Inc.
25 Van Zant St.
Norwalk,  CT  06855
Correspondent Contact GAY CLARKE
Regulation Number878.4450
Classification Product Code
GDY  
Date Received11/17/1986
Decision Date 12/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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