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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, Manual (Resuscitator)
510(k) Number K832495
Device Name FLYNN SERIES III BAG/MASK UNIT-
Applicant
O-TWO SYSTEMS INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
O-TWO SYSTEMS INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5915
Classification Product Code
BTM  
Date Received07/27/1983
Decision Date 09/29/1983
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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