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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K912270
Device Name POLYCATH #WMC-900
Applicant
Worldwide Medical
13794 NW Fourth St.,
Bldg. #210
Sunrise,  FL  33325
Applicant Contact TODD JOHNSON
Correspondent
Worldwide Medical
13794 NW Fourth St.,
Bldg. #210
Sunrise,  FL  33325
Correspondent Contact TODD JOHNSON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/22/1991
Decision Date 08/05/1992
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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