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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K873549
Device Name PEDIATRIC BELLOWS
Applicant
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Applicant Contact PERK CROOK
Correspondent
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Correspondent Contact PERK CROOK
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/31/1987
Decision Date 10/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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