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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 K012842
Device Name V*CARE MANUAL RESUSCITATOR
Applicant
VENTLAB CORP.
2934 HWY. 601 NORTH
MOCKSVILLE,  NC  27028
Applicant Contact MARGE WALLS-WALKER
Correspondent
VENTLAB CORP.
2934 HWY. 601 NORTH
MOCKSVILLE,  NC  27028
Correspondent Contact MARGE WALLS-WALKER
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/23/2001
Decision Date 09/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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