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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 K854632
Device Name ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE
Applicant
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Applicant Contact STEVE GEORGEVICH
Correspondent
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Correspondent Contact STEVE GEORGEVICH
Regulation Number868.5730
Classification Product Code
BTR  
Date Received11/21/1985
Decision Date 01/03/1986
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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