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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 K895913
Device Name STANDARD NEBULIZER HEATER
Applicant
SEAMLESS DIV., PROFESSIONAL MEDICAL PRODUCTS
1909 N.E. 25TH AVE.
OCALA,  FL  32670
Applicant Contact LEE CUTRIGHT
Correspondent
SEAMLESS DIV., PROFESSIONAL MEDICAL PRODUCTS
1909 N.E. 25TH AVE.
OCALA,  FL  32670
Correspondent Contact LEE CUTRIGHT
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/10/1989
Decision Date 12/22/1989
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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