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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 K873930
Device Name AEROSOL DELIVERY SYSTEM (AERO-TECH II)
Applicant
CADEMA MEDICAL PRODUCTS, INC.
P.O. BOX 250
MIDDLETOWN,  NY  10940
Applicant Contact KATHLEEN D BORDONI
Correspondent
CADEMA MEDICAL PRODUCTS, INC.
P.O. BOX 250
MIDDLETOWN,  NY  10940
Correspondent Contact KATHLEEN D BORDONI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/25/1987
Decision Date 12/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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