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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 K900236
Device Name ET-RESTRAINT CAT. # ER 4000
Applicant
Ventlab Corp.
221 Gracie Pl.
Hackensack,  NJ  07601
Applicant Contact GREGORY LAU
Correspondent
Ventlab Corp.
221 Gracie Pl.
Hackensack,  NJ  07601
Correspondent Contact GREGORY LAU
Regulation Number868.5770
Classification Product Code
CBH  
Date Received01/17/1990
Decision Date 02/02/1990
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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