510(k) K974232

ESSENTIAL SHAVER SYSTEM by Gyrus Ent LLC — Product Code EQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1998
Date Received
November 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type