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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Aspirating, Flexible, Connecting
510(k) Number K832865
Device Name FLEX BUBBLE TUBING
Applicant
Sheridan Catheter Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sheridan Catheter Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6740
Classification Product Code
BYY  
Date Received08/23/1983
Decision Date 09/29/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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