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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mask, gas, anesthetic
510(k) Number K944157
Device Name DISPOSABLE, PREFORMED FACE MASK
Applicant
MERIDIAN MEDICAL SYSTEMS, INC.
8102 WOOD LAND DR.
INDIANAPOLIS,  IN  46278
Applicant Contact ROBERT RICHMOND
Correspondent
MERIDIAN MEDICAL SYSTEMS, INC.
8102 WOOD LAND DR.
INDIANAPOLIS,  IN  46278
Correspondent Contact ROBERT RICHMOND
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received08/26/1994
Decision Date 10/03/1994
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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