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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 K942016
Device Name TRACH TIE, VENTILATOR TUBING HOLDER
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 Number868.5770
Classification Product Code
CBH  
Date Received04/26/1994
Decision Date 05/24/1994
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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