510(k) K993089

DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER by Deroyal Cardiovascular, Inc. — Product Code FTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1999
Date Received
September 16, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Accessories
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type