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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K770233
Device Name STERILE SUCTION CATHETER W/CONTROL
Applicant
CHESIRE LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CHESIRE LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6740
Classification Product Code
JOL  
Date Received02/07/1977
Decision Date 04/05/1977
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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