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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 K963601
Device Name MODEL 1920 WASTE GAS SCAVENGER
Applicant
G. Dundas Co.
24301 Roberts Dr.
Black Diamond,  WA  98010
Applicant Contact MARIO SORCI
Correspondent
G. Dundas Co.
24301 Roberts Dr.
Black Diamond,  WA  98010
Correspondent Contact MARIO SORCI
Regulation Number868.5430
Classification Product Code
CBN  
Date Received09/09/1996
Decision Date 04/28/1997
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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