510(k) K822427

SELF-CONTAINED MOBILE OPHTHAL. OPER. . by Surgi-Quip Inc.U — Product Code FSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1982
Date Received
August 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Manual
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type