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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 K080039
Device Name PASSIVE WASTE GAS SCAVENGER, MODEL 14600
Applicant
G. DUNDAS CO.,INC.
24301 ROBERTS DR.
BLACK DIAMOND,  WA  98010
Applicant Contact MARIO SORCI
Correspondent
G. DUNDAS CO.,INC.
24301 ROBERTS DR.
BLACK DIAMOND,  WA  98010
Correspondent Contact MARIO SORCI
Regulation Number868.5430
Classification Product Code
CBN  
Date Received01/07/2008
Decision Date 04/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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