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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mouthpiece, breathing
510(k) Number K853575
Device Name MEDIPART MOUTHPIECE MP-1010
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 Number868.5620
Classification Product Code
BYP  
Date Received08/26/1985
Decision Date 10/29/1985
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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