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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K111413
Device Name BIOGEL (R) INDICATOR (R) UNDERGLOVE
Applicant
Molnlycke Health Care Us, LLC
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Applicant Contact ANGELA L BUNN
Correspondent
Molnlycke Health Care Us, LLC
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Correspondent Contact ANGELA L BUNN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/20/2011
Decision Date 01/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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