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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 K942466
Device Name PROTECTAIDE CPR PROTECTION PACK NO. 17701
Applicant
Protectaide, Inc.
605 White Hills Dr.
Rockwall,  TX  75087
Applicant Contact JAN DAVIS
Correspondent
Protectaide, Inc.
605 White Hills Dr.
Rockwall,  TX  75087
Correspondent Contact JAN DAVIS
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/25/1994
Decision Date 10/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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