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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name valve, non-rebreathing
510(k) Number K993528
Device Name RUSCH EMERGENCY MASK
Applicant
RUSCH, INC.
2450 MEADOWBROOK PKWY.
DULUTH,  GA  30096
Applicant Contact RONALD YOUNG
Correspondent
RUSCH, INC.
2450 MEADOWBROOK PKWY.
DULUTH,  GA  30096
Correspondent Contact RONALD YOUNG
Regulation Number868.5870
Classification Product Code
CBP  
Date Received10/18/1999
Decision Date 05/31/2000
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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