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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K896439
Device Name TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE
Applicant
Ventlab Corp.
221 Gracie Pl.
Hackensack,  NJ  07601
Applicant Contact RICHARD PLAATSMAN
Correspondent
Ventlab Corp.
221 Gracie Pl.
Hackensack,  NJ  07601
Correspondent Contact RICHARD PLAATSMAN
Regulation Number868.5975
Classification Product Code
BZO  
Date Received11/09/1989
Decision Date 01/09/1990
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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