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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K881178
Device Name CUFFCHECK
Applicant
Dhd Medical Products Div. Diemolding Corp.
Division Of Diemolding Corp.
Canastota,  NY  13032
Applicant Contact JEAN WALLACE
Correspondent
Dhd Medical Products Div. Diemolding Corp.
Division Of Diemolding Corp.
Canastota,  NY  13032
Correspondent Contact JEAN WALLACE
Regulation Number868.5750
Classification Product Code
BSK  
Date Received03/18/1988
Decision Date 04/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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