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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 K890822
Device Name CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
Applicant
VENTLAB CORP.
221 GRACIE PLACE
HACKENSACK,  NJ  07601
Applicant Contact RICHARD PLAATSMAN
Correspondent
VENTLAB CORP.
221 GRACIE PLACE
HACKENSACK,  NJ  07601
Correspondent Contact RICHARD PLAATSMAN
Regulation Number868.5975
Classification Product Code
BZO  
Date Received02/17/1989
Decision Date 05/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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