510(k) K781748

IRRIGATION TRAY by Intermed, Inc. — Product Code EYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1978
Date Received
October 17, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Irrigation, Sterile
Device Class
Class II
Regulation Number
876.5980
Review Panel
SU
Submission Type