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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Catheter
510(k) Number K873012
Device Name INFANT CANNULA
Applicant
Gresco International, Inc.
P.O. Box 690188
San Antonio,  TX  78269
Applicant Contact GEORGE E SINKO
Correspondent
Gresco International, Inc.
P.O. Box 690188
San Antonio,  TX  78269
Correspondent Contact GEORGE E SINKO
Regulation Number870.1300
Classification Product Code
DQR  
Date Received08/04/1987
Decision Date 05/02/1988
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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