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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mixer, breathing gases, anesthesia inhalation
510(k) Number K854769
Device Name LNI MGV MEDICAL GAS MIXER
Applicant
P.A. MCCAULEY, INC.
292 PAM LANE
MARIETTA,  GA  30064
Applicant Contact PATRICIA A MCCAULEY
Correspondent
P.A. MCCAULEY, INC.
292 PAM LANE
MARIETTA,  GA  30064
Correspondent Contact PATRICIA A MCCAULEY
Regulation Number868.5330
Classification Product Code
BZR  
Date Received11/27/1985
Decision Date 06/05/1986
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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