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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K913900
Device Name V*CARE MANUAL RESUSCITATOR, CAT#VR-1000
Applicant
Ventlab Corp.
Bldg. 14e Easy St.
P.O. Box 244
Bound Brook,  NJ  08805
Applicant Contact GREGORY LAU
Correspondent
Ventlab Corp.
Bldg. 14e Easy St.
P.O. Box 244
Bound Brook,  NJ  08805
Correspondent Contact GREGORY LAU
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/30/1991
Decision Date 01/07/1992
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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