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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 K150146
Device Name Biogel PI Micro Indicator Underglove
Applicant
Molnlycke Health Care Us, LLC
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Applicant Contact Megan Bevill
Correspondent
Molnlycke Health Care Us, LLC
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Correspondent Contact Megan Bevill
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/22/2015
Decision Date 08/31/2015
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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