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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K152038
Device Name MammoGRIP
Applicant
Women'S Imaging Solutions Enterprises, LLC
226 Wilson Dr.
Cresskill,  NJ  07626
Applicant Contact Nancy DeRobertis
Correspondent
Namsa
4050 Olson Memorial Hwy.
Minneapolis,  MN  55422
Correspondent Contact Erika Huffman
Regulation Number892.1710
Classification Product Code
IZH  
Date Received07/22/2015
Decision Date 12/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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