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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Rebreathing, Radionuclide
510(k) Number K881812
Device Name AERO-MIST NEBULIZER
Applicant
Cadema Medical Products, Inc.
P.O. Box 250
Middletown,  NY  10940
Applicant Contact KATHLEEN BORDONI
Correspondent
Cadema Medical Products, Inc.
P.O. Box 250
Middletown,  NY  10940
Correspondent Contact KATHLEEN BORDONI
Regulation Number892.1390
Classification Product Code
IYT  
Date Received04/28/1988
Decision Date 07/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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