510(k) K961124

THE NAUTILUS by Rand Scientific Corp. — Product Code FZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1996
Date Received
March 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
Review Panel
SU
Submission Type