510(k) K980166

LIGHTSOURCE OR ILLUMINATOR by Cuda Products Co. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1998
Date Received
January 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type