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510(k) K953042

E-Z BREATHERS by E-Z Kare Good Health Systems, Inc. — Product Code LWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1995
Date Received
June 15, 1995
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

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