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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 K991617
Device Name FACE-2-FACE CPR PROTECTION SHIELD
Applicant
Whiteline Plastics, Inc.
6800 Columbus Rd.
Mississauga, Ontario,  CA L5T 2G1
Applicant Contact WALLY SIMPSON
Correspondent
Whiteline Plastics, Inc.
6800 Columbus Rd.
Mississauga, Ontario,  CA L5T 2G1
Correspondent Contact WALLY SIMPSON
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/10/1999
Decision Date 11/03/1999
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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