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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 K944512
Device Name TRUZONE PFM DISPOSABLE MOUTHPIECE
Applicant
MONAGHAN MEDICAL CORP.
FRANKLYN BLDG., RT. 9 NORTH
P.O. BOX 2805
PLATTSBURGH,  NY  12901
Applicant Contact JAMES A COCHIE
Correspondent
MONAGHAN MEDICAL CORP.
FRANKLYN BLDG., RT. 9 NORTH
P.O. BOX 2805
PLATTSBURGH,  NY  12901
Correspondent Contact JAMES A COCHIE
Regulation Number868.5620
Classification Product Code
BYP  
Date Received09/15/1994
Decision Date 11/02/1994
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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