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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 K902896
Device Name 49-610 NIKO-NOSE FIXATION TAPE
Applicant
Nikomed U.S.A., Inc.
1300 Airport Rd., Suite C
North Brunswick,  NJ  08902
Applicant Contact DONALD EPSTEIN
Correspondent
Nikomed U.S.A., Inc.
1300 Airport Rd., Suite C
North Brunswick,  NJ  08902
Correspondent Contact DONALD EPSTEIN
Regulation Number868.5770
Classification Product Code
CBH  
Date Received07/03/1990
Decision Date 10/23/1990
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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