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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 K822040
Device Name POWERED EMERGENCY VENTILATOR
Applicant
FRASER HARLAKE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
FRASER HARLAKE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/12/1982
Decision Date 08/19/1982
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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