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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 K871448
Device Name MODEL 105 VENTILATOR
Applicant
DEVELOPMED CORP.
3346 WALNUT BEND LN.
HOUSTON,  TX  77042
Applicant Contact CHARLES S BOYD
Correspondent
DEVELOPMED CORP.
3346 WALNUT BEND LN.
HOUSTON,  TX  77042
Correspondent Contact CHARLES S BOYD
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/13/1987
Decision Date 05/07/1987
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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