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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 K881931
Device Name RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR
Applicant
RONDEX PRODUCTS, INC.
P.O. BOX NO. 1829
ROCKFORD,  IL  61110
Applicant Contact GENE R BALDWIN
Correspondent
RONDEX PRODUCTS, INC.
P.O. BOX NO. 1829
ROCKFORD,  IL  61110
Correspondent Contact GENE R BALDWIN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/09/1988
Decision Date 07/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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