510(k) K963326

BREATHE FIT by Cambridge Assoc. — Product Code LWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1997
Date Received
August 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Nasal
Device Class
Class I
Regulation Number
874.3900
Review Panel
EN
Submission Type