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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vacuum Sample, With Anticoagulant
510(k) Number K922858
Device Name MULTIDRAW SYSTEM
Applicant
Cambridge Multi-Draw, Inc.
56 Creighton St.
Cambridge,  MA  02140
Applicant Contact STEPHEN WEBSTER
Correspondent
Cambridge Multi-Draw, Inc.
56 Creighton St.
Cambridge,  MA  02140
Correspondent Contact STEPHEN WEBSTER
Regulation Number862.1675
Classification Product Code
GIM  
Date Received06/15/1992
Decision Date 11/16/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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