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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 K862784
Device Name MP-XMO DISPOSABLE FACE MASK
Applicant
MEDIPART JERRY ALEXANDER
607 SPRING BEACH RD.
CARY,  IL  60013
Applicant Contact JERRY ALEXANDER
Correspondent
MEDIPART JERRY ALEXANDER
607 SPRING BEACH RD.
CARY,  IL  60013
Correspondent Contact JERRY ALEXANDER
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received07/23/1986
Decision Date 08/01/1986
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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