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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lubricant, patient
510(k) Number K103718
Device Name DYNACOR LUBRICATION GEL
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact MATT CLAUSEN
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact MATT CLAUSEN
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received12/21/2010
Decision Date 05/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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