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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, sponge, surgical
510(k) Number K061316
Device Name MEDLINE SURGICAL SPONGE SCANNER
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact LARA N SIMMONS
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact LARA N SIMMONS
Regulation Number880.2740
Classification Product Code
LWH  
Date Received05/11/2006
Decision Date 11/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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