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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K896005
Device Name SMALL CATHETER INFLATOR
Applicant
Allied Systems Co.
8 Garden Path
Farmington,  CT  06032
Applicant Contact RICHARD J ZEAMER
Correspondent
Allied Systems Co.
8 Garden Path
Farmington,  CT  06032
Correspondent Contact RICHARD J ZEAMER
Regulation Number870.1650
Classification Product Code
MAV  
Date Received10/13/1989
Decision Date 02/26/1990
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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