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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K033559
Device Name 12-LEAD GLOVE
Applicant
Ineedmd
860 Canal St.
Stamford,  CT  06902
Applicant Contact IRVING WIESEN, ESQ.
Correspondent
Ineedmd
860 Canal St.
Stamford,  CT  06902
Correspondent Contact IRVING WIESEN, ESQ.
Regulation Number870.2360
Classification Product Code
DRX  
Date Received11/12/2003
Decision Date 12/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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