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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 K990098
Device Name VENTLAB VERIFY II
Applicant
Ventlab Corp.
P.O. Box 4341
Crofton,  MD  21114 -4341
Applicant Contact E J SMITH
Correspondent
Ventlab Corp.
P.O. Box 4341
Crofton,  MD  21114 -4341
Correspondent Contact E J SMITH
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/12/1999
Decision Date 02/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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