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510(k) K884922

THE BREATHE EASE NURSERY VAPOR TENT by Cal-Trends Products — Product Code FNC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1989
Date Received
November 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tent, Pediatric Aerosol
Device Class
Class II
Regulation Number
868.5710
Review Panel
AN
Submission Type