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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K932083
Device Name XDCS-100
Applicant
Microwave Medical Systems, Inc.
9 Goldsmith St.
P.O. Box 188
Littleton,  MA  01460
Applicant Contact JAMES G CUDMORE
Correspondent
Microwave Medical Systems, Inc.
9 Goldsmith St.
P.O. Box 188
Littleton,  MA  01460
Correspondent Contact JAMES G CUDMORE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received04/30/1993
Decision Date 12/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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