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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Occluder, Catheter Tip
510(k) Number K844918
Device Name OCCLUSION & OCCLUSION-IRRIGATION
Applicant
Clincal Instruments Corp.
9 Cross St.
Dudley,  MA  01570
Applicant Contact MICHAEL L POLANYI
Correspondent
Clincal Instruments Corp.
9 Cross St.
Dudley,  MA  01570
Correspondent Contact MICHAEL L POLANYI
Regulation Number870.1370
Classification Product Code
DQT  
Date Received12/19/1984
Decision Date 08/05/1985
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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