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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 K950855
Device Name ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS
Applicant
Adam Spence Corp.
1746 Rt. 34
P.O. Box 1467
Wall,  NJ  07719
Applicant Contact ADAM SANFORD
Correspondent
Adam Spence Corp.
1746 Rt. 34
P.O. Box 1467
Wall,  NJ  07719
Correspondent Contact ADAM SANFORD
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/27/1995
Decision Date 05/30/1995
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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