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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Tracheal Tube
510(k) Number K921698
Device Name CN ENDOTRACHEAL TUBE HOLDER
Applicant
N-C-N Products Co.
1315 Glenmore Ct.
Barrington,  IL  60010
Applicant Contact ABDEL NOURALDIN
Correspondent
N-C-N Products Co.
1315 Glenmore Ct.
Barrington,  IL  60010
Correspondent Contact ABDEL NOURALDIN
Regulation Number868.5770
Classification Product Code
CBH  
Date Received04/08/1992
Decision Date 09/15/1992
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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