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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K911465
Device Name INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
Applicant
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Applicant Contact ALBERTO VELEZ
Correspondent
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Correspondent Contact ALBERTO VELEZ
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/03/1991
Decision Date 10/18/1991
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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