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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tent, Pediatric Aerosol
510(k) Number K884922
Device Name THE BREATHE EASE NURSERY VAPOR TENT
Applicant
Cal-Trends Products
825 N. Harbor Blvd.
Fullerton,  CA  92632
Applicant Contact ALAN MORTON
Correspondent
Cal-Trends Products
825 N. Harbor Blvd.
Fullerton,  CA  92632
Correspondent Contact ALAN MORTON
Regulation Number868.5710
Classification Product Code
FNC  
Date Received11/28/1988
Decision Date 02/03/1989
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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