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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 K963092
Device Name MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER
Applicant
Adam Spencer Corp.
19526 E. Lake Dr.
Miami,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
Adam Spencer Corp.
19526 E. Lake Dr.
Miami,  FL  33015
Correspondent Contact AL WEISENBORN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/08/1996
Decision Date 01/13/1997
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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