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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K031442
Device Name PBN GUIDEWIRES
Applicant
Medical Device Technologies, Inc.
3600 S.W 47th Ave.
Gainesville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Medical Device Technologies, Inc.
3600 S.W 47th Ave.
Gainesville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/06/2003
Decision Date 08/13/2003
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
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