Device Classification Name	Nebulizer (Direct Patient Interface)
510(k) Number	K874395
Device Name	RESPIRGARD II NEBULIZER SYSTEM
Applicant	Marquest Medical Products, Inc. 11039 E. Lansing Cir. Englewood,  CO  80112
Applicant Contact	JOHN ADAMS
Correspondent	Marquest Medical Products, Inc. 11039 E. Lansing Cir. Englewood,  CO  80112
Correspondent Contact	JOHN ADAMS
Regulation Number	868.5630
Classification Product Code	CAF
Date Received	10/28/1987
Decision Date	12/21/1987
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