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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K851832
Device Name NAMAN POTTS COURNAND NEEDLE
Applicant
MANAN MANUFACTURING CO., INC.
8020 NORTH CENTRAL PARK AVE.
SKOKIE,  IL  60076
Applicant Contact MANFRED MITTERMEIER
Correspondent
MANAN MANUFACTURING CO., INC.
8020 NORTH CENTRAL PARK AVE.
SKOKIE,  IL  60076
Correspondent Contact MANFRED MITTERMEIER
Regulation Number870.4500
Classification Product Code
DWS  
Date Received04/26/1985
Decision Date 07/11/1985
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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