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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K962389
Device Name EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
Applicant
UNOMEDICAL SDN BHD
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Applicant Contact PATRICK J LAMB
Correspondent
UNOMEDICAL SDN BHD
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Correspondent Contact PATRICK J LAMB
Regulation Number868.5730
Classification Product Code
BTR  
Date Received06/20/1996
Decision Date 11/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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