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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resuscitator, Manual, Non Self-Inflating
510(k) Number K013308
Device Name VENTLAB HYPERINFLATION BAG SYSTEM
Applicant
Ventlab Corp.
2934 Hwy. 601 N.
Mocksville,  NC  27028
Applicant Contact MARGE WALLS-WALKER
Correspondent
Ventlab Corp.
2934 Hwy. 601 N.
Mocksville,  NC  27028
Correspondent Contact MARGE WALLS-WALKER
Regulation Number868.5905
Classification Product Code
NHK  
Date Received10/04/2001
Decision Date 12/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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