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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, Lead (Dedicated Instruments)
510(k) Number K900822
Device Name HYDRO-SIL(TM) COATED GUIDEWIRES
Applicant
National-Standard Medical Products
4445-360 SW 35th Terrace
Gainesville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
National-Standard Medical Products
4445-360 SW 35th Terrace
Gainesville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number862.3550
Classification Product Code
DOX  
Date Received02/21/1990
Decision Date 07/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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