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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K862199
Device Name MEDTECH C.P.R. MASK
Applicant
THE MEDTECH GROUP, INC.
SIX CENTURY RD.
SOUTH PLANIFIELD,  NJ  07080
Applicant Contact LAURENCE G WESSER
Correspondent
THE MEDTECH GROUP, INC.
SIX CENTURY RD.
SOUTH PLANIFIELD,  NJ  07080
Correspondent Contact LAURENCE G WESSER
Regulation Number868.5110
Classification Product Code
CAE  
Date Received06/10/1986
Decision Date 06/13/1986
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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