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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 K960587
Device Name CPROTECTOR 2000
Applicant
CERTIFIED SAFETY MFG., INC.
1400 CHESTNUT
KANSAS CITY,  MO  64127
Applicant Contact HOWARD GERSON
Correspondent
CERTIFIED SAFETY MFG., INC.
1400 CHESTNUT
KANSAS CITY,  MO  64127
Correspondent Contact HOWARD GERSON
Regulation Number868.5870
Classification Product Code
CBP  
Date Received02/12/1996
Decision Date 07/21/1997
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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