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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 K974745
Device Name MANAN GWI GUIDE WIRE INTRODUCER
Applicant
Medical Device Technologies, Inc.
4445 SW 35th Terrace
Suite 310
Gainsville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Medical Device Technologies, Inc.
4445 SW 35th Terrace
Suite 310
Gainsville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number870.1390
Classification Product Code
DRC  
Date Received12/19/1997
Decision Date 04/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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