510(k) K821665

PEDESTAL EXAMINING TABLE by American Hamilton — Product Code GDC

K821665 is an FDA 510(k) premarket notification submitted by American Hamilton for the device "PEDESTAL EXAMINING TABLE". The FDA issued a decision of Substantially Equivalent on June 24, 1982. The device falls under product code GDC (Table, Operating-Room, Electrical), a Class I device regulated under 21 CFR 878.4960. American Hamilton has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1982
Date Received
June 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Electrical
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type