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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 K880287
Device Name TRU-TRAC COILED GUIDEWIRE
Applicant
N-S Medical Products
4435 SW 35th Terrace
Suite 360
Gainesville,  FL  32608
Applicant Contact KEITH L STAHL
Correspondent
N-S Medical Products
4435 SW 35th Terrace
Suite 360
Gainesville,  FL  32608
Correspondent Contact KEITH L STAHL
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/25/1988
Decision Date 09/12/1988
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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