510(k) K782092

ARMBOARD CVER, DISPOSABLE by Anago, Inc. — Product Code FSE

K782092 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "ARMBOARD CVER, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on January 10, 1979. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Anago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1979
Date Received
December 14, 1978
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