510(k) K962256

GALILEO HYSTEROSCOPES AND LAPAROSCOPES by Galileo Electro-Optics Corp. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1996
Date Received
June 12, 1996
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