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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 K882977
Device Name ASK-300
Applicant
Medical Repackers Co.
P.O. Box 1500
Fort Payne,  AL  35967
Applicant Contact BILLY A HODGES
Correspondent
Medical Repackers Co.
P.O. Box 1500
Fort Payne,  AL  35967
Correspondent Contact BILLY A HODGES
Regulation Number870.1300
Classification Product Code
DQR  
Date Received07/15/1988
Decision Date 01/05/1989
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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