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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nebulizer (direct patient interface)
510(k) Number K930574
Device Name AEROCHAMBER W/MASK, MODIFIED
Applicant
MONAGHAN MEDICAL CORP.
FRANKLYN BLDG RT. 9 NORTH
P.O. BOX 978
PLATTSBURGH,  NY  12901
Applicant Contact JAMES A COCHIE
Correspondent
MONAGHAN MEDICAL CORP.
FRANKLYN BLDG RT. 9 NORTH
P.O. BOX 978
PLATTSBURGH,  NY  12901
Correspondent Contact JAMES A COCHIE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/04/1993
Decision Date 01/24/1994
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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