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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 K992722
Device Name PRIMEAIRE
Applicant
THAYER MEDICAL CORP.
4575 SOUTH PALO VERDE RD.,
SUITE 337
TUCSON,  AZ  85714
Applicant Contact DAVID T SLADEK
Correspondent
THAYER MEDICAL CORP.
4575 SOUTH PALO VERDE RD.,
SUITE 337
TUCSON,  AZ  85714
Correspondent Contact DAVID T SLADEK
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/13/1999
Decision Date 11/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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