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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Tumor Marker, Monitoring, Bladder
510(k) Number K021231
Device Name NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
Applicant
Matritech, Inc.
330 Nevada St., 2nd Floor
Newton,  MA  02460
Applicant Contact MELODIE R DOMURAD
Correspondent
Matritech, Inc.
330 Nevada St., 2nd Floor
Newton,  MA  02460
Correspondent Contact MELODIE R DOMURAD
Regulation Number866.6010
Classification Product Code
MMW  
Date Received04/18/2002
Decision Date 07/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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