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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K913039
Device Name FLLYNN(R) GENESIS AC
Applicant
O-TWO SYSTEMS INTL., INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO,  CA L5S 1C8
Applicant Contact JOE LASSALINE
Correspondent
O-TWO SYSTEMS INTL., INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO,  CA L5S 1C8
Correspondent Contact JOE LASSALINE
Regulation Number868.5925
Classification Product Code
BTL  
Date Received07/09/1991
Decision Date 08/25/1992
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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