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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K110930
Device Name ACTIVE WASTE GAS SCAVENGER
Applicant
G. DUNDAS CO.,INC.
24301 ROBERTS DR.
BLACK DIAMOND,  WA  98010
Applicant Contact MICHELLE NORRIE
Correspondent
G. DUNDAS CO.,INC.
24301 ROBERTS DR.
BLACK DIAMOND,  WA  98010
Correspondent Contact MICHELLE NORRIE
Regulation Number868.5430
Classification Product Code
CBN  
Date Received04/04/2011
Decision Date 06/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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