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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 K820952
Device Name OPTI-MIST
Applicant
CORPAK CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CORPAK CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/06/1982
Decision Date 04/29/1982
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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