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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 K841789
Device Name SECHRIST AIR-OXYGEN MIXER & ANCILLARY
Applicant
SHILEY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SHILEY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5330
Classification Product Code
BZR  
Date Received04/30/1984
Decision Date 07/26/1984
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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