510(k) K844652

C.A.S.E. CONTAINER by General Medical Co. — Product Code FSM

K844652 is an FDA 510(k) premarket notification submitted by General Medical Co. for the device "C.A.S.E. CONTAINER". The FDA issued a decision of Substantially Equivalent on December 12, 1984. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. General Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1984
Date Received
November 29, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type