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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 K970991
Device Name DATEX ENGSTOM MANUAL RESUSCITATOR
Applicant
PROMEDIC, INC.
6329 WEST WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
PROMEDIC, INC.
6329 WEST WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received03/19/1997
Decision Date 06/16/1997
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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