510(k) K000108

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 by Bhk Holding — Product Code EMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2000
Date Received
January 14, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Epistaxis
Device Class
Class I
Regulation Number
874.4100
Review Panel
EN
Submission Type