510(k) K955119

SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES by Symbiosis Corp. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1996
Date Received
November 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type