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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 K955520
Device Name RESCUE BREATHER
Applicant
International Safety, Inc.
2322 Douglas Dr.
Eugene,  OR  97405
Applicant Contact ROBERT S MCQUATE
Correspondent
International Safety, Inc.
2322 Douglas Dr.
Eugene,  OR  97405
Correspondent Contact ROBERT S MCQUATE
Regulation Number868.5870
Classification Product Code
CBP  
Date Received12/04/1995
Decision Date 10/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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