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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 K934117
Device Name STABILTUBE
Applicant
Garrett Medical Products
203 Via Serena Rd.
Rancho Santa Margarita,  CA  92688
Applicant Contact JOHN D CALEBAUGH
Correspondent
Garrett Medical Products
203 Via Serena Rd.
Rancho Santa Margarita,  CA  92688
Correspondent Contact JOHN D CALEBAUGH
Regulation Number868.5730
Classification Product Code
BTR  
Date Received08/24/1993
Decision Date 10/25/1993
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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