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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 K914283
Device Name THAYER EXPANSION CHAMBER METERED DOSE INHALER
Applicant
Thayer Medical Corp.
4500 E. Speedway Blvd.
Suite 20
Tucson,  AZ  85712
Applicant Contact DAVID SLADEK
Correspondent
Thayer Medical Corp.
4500 E. Speedway Blvd.
Suite 20
Tucson,  AZ  85712
Correspondent Contact DAVID SLADEK
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/24/1991
Decision Date 02/26/1992
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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