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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K902520
Device Name AIR PLUS NEBULIZER
Applicant
Diamond Medical Equipment, Inc.
95-40 157th St.
Jamaica,  NY  11433
Applicant Contact HARVEY DIAMOND
Correspondent
Diamond Medical Equipment, Inc.
95-40 157th St.
Jamaica,  NY  11433
Correspondent Contact HARVEY DIAMOND
Regulation Number868.6250
Classification Product Code
BTI  
Date Received06/07/1990
Decision Date 03/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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