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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K936247
Device Name MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
Applicant
Medicon Instruments, Inc.
Colubmia Sq.
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Medicon Instruments, Inc.
Colubmia Sq.
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number870.1390
Classification Product Code
DRC  
Date Received12/30/1993
Decision Date 05/19/1994
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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